Manager Of Regulatory Affairs Jobs

Job Title: Senior Director of Regulatory Affairs Company: Hobbs & Towne, Inc. Location: Winston Salem, NC Description: Senior Director of Regulatory Affairs Reports to the Vice President of Clinical Development & Regulatory Affairs The primary purpose of the Senior Director of Regulatory Affairs is to provide overall management, structure, and regulatory leadership for the development and implementation of all regulatory and quality assurance strategies/tactics from progression of drug candidates through R & D to clinical trial, and through the regulatory process to final market approval and maintenance of approved new drug applications.

Job Title: Associate Director Regulatory Affairs Company: Location: Ellicott City, MD Description: CSG has become a leading resource for clinical professionals seeking new contract, contract-to-hire, and/or direct opportunities. Our reputation allows our candidates access to the most desirable positions in the industry depending on where their respective interests lie. We offer full benefits including medical, dental, vision, life insurance, short/long-term disability, 401K, referral bonuses, training reimbursement, relocation, and continuing education. CSG is also in a position to work with individuals on a 1099 basis. Our firm is consistently seeking top-notch professionals to join our team in a consulting capacity. Should your interest be a permanent role, CSG has multiple opportunities to suit your needs. The selected candidate will be responsible for compiling and processing US IND, CTD, Annual reports, DMF, NDA and BLA submissions and assisting with all Regulatory Affairs /Quality Assurance department needs. In this role, you will ensure timeliness of deliverables; edit/format/review regulatory documents; and work with staff in resolving regulatory issues and/or problems. Ensure that the company adheres to all applicable regulations. Additionally, you may serve as the team member for specific projects; be responsible for gathering and entering regulatory information related to specific projects; perform regulatory and/or quality assurance reviews of data or reports; attend project meetings, professional meetings, seminars and workshops; and document all phases of involvement in any specific project

Job Title: Regulatory Affairs Manager Company: Westat Location: Rockville, MD Description: Regulatory Affairs Manager (Requisition # WJ/HS/8426) ORIGINAL JOB LISTING Job Title: Regulatory Affairs Manager JobCode: WJ/HS/8426 Division: Research Staff JobCategories: Quality Assurance / Testing, Healthcare - All Status: Full-Time Salaried WestatArea: Health and Medical Studies Location: Rockville, MD Description: The Regulatory Affairs (RA) Unit of the Clinical Trials area is seeking an individual who will have day-to-day management responsibility for the RA Unit under the direction of the RA/QA director. Qualified candidates will have a strong regulatory background with an emphasis on clinical trials and clinical safety reporting. Responsibilities include: managing ongoing regulatory projects; IND development and maintenance; compliance reviews of protocols, informed consents and other trial documents; oversight of the organization and maintenance of Trial Master Files and SOP review and compliance. Individual will also be responsible for the preapproval pharmacovigilance component of the RA Unit including oversight of the safety database, reporting procedures, and review and management of the Serious Adverse Experience reports (SAE) for domestic, international, commercial, and Government-sponsored clinical trials; RA Unit development and planning; and participation in proposal writing and project team meetings. A bachelors degree in a life science or health care curriculum, with 4+ years of regulatory experience in the pharmaceutical, biotech, or clinical research industry, including management experience, is required. Must be able to work in a team environment and possess strong organizational, time-management, and written and oral communication skills. Knowledge regarding Federal regulations, and FDA, ICH/GCP, and OHRP guidelines is required. Proficiency in Microsoft Office including Access is desirable. Westat Homepage Employees Worldwide: 3,400 Employees in Local Area: 1,900 Annual Revenue: $425,000,000 Westat, headquartered in Rockville, Maryland, near Washington, DC, is an employee-owned research corporation serving agencies of the U.S. Government, state and local governments, businesses, and foundations. We conduct surveys and program evaluations, provide statistical research, and offer related services. Our multiproject environment provides career opportunities in health, energy, education, transportation, the environment, human services, and the workforce. We combine the relevant research area expertise with the capabilities to perform major survey research projects: study design and analysis, methodology, survey data collection, information technology, and web evaluation and design. Westat offers information technology and data processing capabilities, including developing computer-assisted interviewing systems and integrating them with the survey process. Our staff includes senior statisticians who have international reputations in survey sample design and statistical analysis. We also provide wide-ranging capabilities with statistical processing and data management systems. Westat is a full-service research organization. Westat's diverse benefits program is our way of sharing our success with employees, rewarding teamwork, and encouraging professional growth: Employee Stock Ownership 401(k) Annual Cash Bonus Professional Development Programs Insurance Coverage

Job Title: Manager/Sr. Manager of Regulatory Affairs Company: Ironwood Pharmaceuticals, Inc. Location: Cambridge, MA Description: Job Code: GRMRA Category: Medicinal Chemistry To apply, send email with a subject of “Job Code GRMRA” to Register to View Please include a CV and cover letter with your email message. Position description: The Manager of Regulatory Affairs participates in the development and implementation of regulatory strategy for specific programs. Working in a team environment, the Manager will be responsible for planning and coordinating all aspects of regulatory submissions necessary to support clinical trials and product registration. The Regulatory Affairs Manager will represent the department on multidisciplinary product development teams. Responsibilities: Works with the Sr. Director to implement the regulatory strategy to move our products through development and regulatory approval Assesses and communicates regulatory requirements for clinical, preclinical and CMC submissions and programs to assure that all development activities are in compliance with applicable regulations and guidelines — This will entail keeping abreast of changes and meaningful trends in the regulatory environment in the US and pertinent international jurisdictions Participates on project teams or subteams for the planning of activities needed to meet development program objectives — This includes preparing and managing timelines for all regulatory submission such as initial INDs, IND amendments, CTx, NDAs, meeting requests, briefing books etc. Serves as primary liaison with regulatory authorities and participates in meetings with regulatory agencies Writes FDA correspondence, meeting minutes, and introductory sections of regulatory submissions Reviews documentation associated with regulatory submissions such as clinical study reports, preclinical reports and CMC reports and information Works with the Regulatory Operations to develop submissions in electronic and legacy format Cooperates with the regulatory team and the cross-functional team to promote an environment of knowledge sharing and team effectiveness Requirements: § Knowledgeable and experienced in interpretation of regulations and guidelines related to drug development § Capable of strategic thinking and proposing innovative solutions to regulatory problems § Demonstrates excellent teamwork and communication skills with ability to impact and influence the decisions of a team Minimum Education Requirements Bachelor's Degree in chemistry, biology or health-related major. Advanced degrees are desirable but not required. At least 5 years experience in regulatory affairs in the drug industry. Experience with original IND or NDA submissions. Ironwood Pharmaceuticals is an equal opportunity employer welcoming diversity in our workforce.

Job Title: Regulatory Affairs Manager or Sr. Assoc. for Pharma. Ind. Company: Anchen Pharmaceuticals, Inc. Location: Irvine, CA Description: Anchen Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of extended release (ER) generic products; primarily for patients in the United States. We are seeking to grow our company in every department. Company is in "start-up" mode and now is the best time to get in and make a difference in the company. We offer competitive compensation and comprehensive benefit package. Summary: Under general direction and using government guidance’s and regulations, responsible for successfully filing Abbreviated New Drug Application submissions, supplement submissions, Annual Reports and Adverse Event Reporting. Primary contact with regulatory authorities for assigned projects and products. Determines nature and scope of information to be generated to successfully file required regulatory documents. Keeps company informed of significant regulatory issues that affect assigned products/projects. : Under general direction and using government guidance’s and regulations, responsible for successfully filing Abbreviated New Drug Application submissions, supplement submissions, Annual Reports and Adverse Event Reporting. Primary contact with regulatory authorities for assigned projects and products. Determines nature and scope of information to be generated to successfully file required regulatory documents. Keeps company informed of significant regulatory issues that affect assigned products/projects. Impact of Position: The Manager makes initial determination of information required for submission and is primary contact person between internal departments and FDA Reviewers as to technical soundness and regulatory requirements in the application. Any delay in approval of theses applications will significantly affect Anchen’s ability to compete in the market place. Essential Job Functions : This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks. · Reviews selected documents in detail to ensure clarity of data presentation, accuracy of data interpretation, logic, consistency and compliance with Regulatory requirements. Ensures that regulatory quality is incorporated at each step of the document development e.g. troubleshoots data and resolves problems with technical issues such as test methods and instrumentation. Anticipates regulatory issues early in drug development process and works to eliminate/minimize regulatory barriers. · Determines necessity for communication with FDA for CMC and/or Bioequivalency issues. Negotiates agreements on issues needing further clarification. · Develops and implements regulatory strategies/advice for new product development and life cycle of the product. Communicates regulatory information to product team members. Maintains awareness of all regulatory activities on assigned projects. Works to minimize regulatory issues and helps prevent unnecessary regulatory delays. · Develops submission strategies for manual and electronic submissions of new ANDAs, supplements and annual reports. Takes lead in electronic assembly and publishing of regulatory submissions. Reviews regulatory submissions for accuracy and completeness. · Provides draft labeling (labels, package inserts, carton) for submission. Monitors FDA labeling website to ensure that labeling is current with the FDA approved labeling for the assigned application. · Carries out managerial responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws. · Reviews change control in order to assign appropriate regulatory determination and ensure proper supporting documentation is available to accurately define change. · Provides support, direction and coaching to subordinate employees in the areas of hiring, training, disciplinary action, problem resolution, planning, and work assignment delegation. Conducts performance evaluations for direct reports. · Ensure compliance with all Company policies and procedures, including safety rules and regulations · Performs related duties as assigned. Required Knowledge and Skills : Knowledge : · Strong familiarity with FDA, ICH and cGMP standards, guidelines, regulatory compliance regulations and the overall regulatory environment as related to the pharmaceutical industry. Aware of pertinent Federal and State laws related to pharmaceutical regulatory affairs. Ability to apply appropriate regulations to resolve the regulatory issue. · Strong familiarity of the drug development process. Ability to proactively assess appropriateness of data. · Supervision and training practices and methods. · Business, scientific and personal computer software applications, e.g MS Word, Excel, Access, etc. · Business English usage such as, spelling, grammar and punctuation. · Recruiting, interviewing and selecting of applicants in accordance with established employment practices and methods. Skills: · Create, plan and implement team goals, objectives and practices for effective, efficient and cost effective management of allocated resources. · Respond to general and/or sensitive inquiries from management, employees and regulatory agencies. Establish and maintain co-operative working relationships with key clients and contacts within the organization. · Communicate clearly and concisely, both orally and in writing, when interpreting and applying Federal, state and local policies, procedures, laws and regulations. · Manage multiple projects, duties and assignments. · Analyze problems, identify alternate solutions, and implement recommendations for resolution. Formulate and provide supporting data for the Company’s position on specific issues in light of current regulatory strategy. Minimum Qualifications : Bachelors of Science Degree from an accredited college or university, and three (3) to five (5) years Regulatory Affairs pharmaceutical technical work experience or an equivalent combination of education and experience. Physical Requirements and Working Conditions : Incumbents in this class are subject to extended periods of sitting, standing and walking, vision to monitor, moderate noise levels and frequent business travel. Work is performed in an office environment.

Job Title: Manager, Regulatory Affairs Company: Location: Boston, MA Description: Description: Posting Title: Regulatory Affairs Manager Location: Cambridge, MA Department: Regulatory Classification: Clinical Research Required Travel: Yes Required Education: Bachelors Degree Relocation: Yes Job Description Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, inflammation, autoimmune diseases, cancer, pain and bacterial infection. Position Overview: The Regulatory Affairs Manger participates in the development and implementation of regulatory strategy for specific programs. Working in a team environment, the Manager will be responsible for planning and coordinating all aspects of regulatory submissions necessary to support clinical trials and product registration. The Regulatory Affairs Manager will represent the department on multidisciplinary product development sub-teams. Key Responsibilities: - Coordinates all aspects of regulatory submissions for assigned projects - Applies knowledge of regulatory requirements to the review of scientific documentation relevant to regulatory submissions - Actively contributes to the development and implementation of regulatory strategy for assigned projects - Analyzes relevant new regulations/guidelines and communicates impact to company - Prepares and delivers effective presentations for cross-functional internal audiences - Mentors Regulatory Affairs staff in area of expertise and may have supervisory responsibility - Represents Regulatory Affairs at relevant internal and external meetings - Performs other duties as assigned Minimum Requirements - B.S. (or equivalent degree) and 5 - 8 years of relevant work experience; M.S. (or equivalent degree) and 2 - 5 years relevant work experience - Knowledgeable and experienced in interpretation of regulations and guidelines related to drug development - Capable of strategic thinking and proposing innovative solutions to regulatory problems - Demonstrates excellent communication skills with ability to impact and influence the decisions of a team Minimum Education Requirements Bachelor's Degree in chemistry, biology or health-related major Apply Now

Job Title: Regulatory Affairs Manager Medical Devices Company: Management Recruiters of Sioux Falls Location: Detroit, MI Description: Regulatory Affairs Manager- Medical Device- Domestic and International Specialist! Detroit , MI Our client, a specialty medical device company nearing its 10 year anniversary is searching for an experienced candidate with first hand or relevant experience in the successful implementation of new and existing product lines. This senior manager will report directly to the Vice President and, working with the senior management team, participate in the selection and prioritization of product candidates, the preparation and submission of regulatory documents, and primary responsibility for the selection and continuous oversight of contracted manufacturers. The ideal candidate will have GMP experience as well as a good working knowledge of FDA requirements and 510(k) submissions. International regulatory (EU, Japan) experience is a plus. This person will be in charge of domestic and international regulatory audits and submissions and will have direct responsibility for a 2-3 person team. Essential Duties & Responsibilities Liaison with regulatory agencies having jurisdiction over the company???s products Regulatory oversight of investigation and commercial medical device products Coordinate regulatory functions and filings as part of the product development teams and interact closely with manufacturing, clinical and other R&D functions Serve as an internal resource and expert for the company in the area of regulatory policy and strategy Manage relationships with regulatory consultants when utilized Review and approve regulatory filings prior to submission, including utilization of the company???s electronic document management and filing systems Establish and oversee the programs of post-approval as may be required by regulatory authorities and make regular reports thereon to the Board of Directors Requirements Bachelors Degree in disciplines such as Pharmaceutical Science, Chemistry, and Biology Masters Degree in Regulatory Affairs is highly preferred 5+ years relevant experience in pharmaceutical product development Senior-level management of an approved new drug from development stages to market launch Strong practical knowledge of regulatory affairs issues both domestic and international is preferred Strong working knowledge of regulatory procedures and proven success in leading the coordination and preparation of document packages for regulatory submissions from all disciplines within the Company Extensive knowledge and background working with the FDA/CBER and other regulatory agencies Effective communication skills in English language (writing, speaking, comprehending) Knowledge of Microsoft Office package including Word, Outlook, Excel, Project Commitment to the success of the business Ability to work independently and as part of a team Must be innovative, dynamic with ethical standards of integrity and quality, and caring attitude Capable of performing other duties as assigned Authorized to legally work in the United States without Visa sponsorship IMPORTANT: Initially, you do not need to send me your resume, disclose your name or the company you work for. All you need to do is call me at Register to View ext. 221. I understand confidentiality is ???critical??? in relation to this opportunity as it???s more important for me to find the perfect match than to ???initially??? know your name. Communication in Confidence??? Register to View Ext. 221 Compensation: Compensation for this position ranges from $100k to $140K with bonuses ranging from 10-30% of base salary plus profit sharing and matching 401K. Benefits $100k-$140K base salary Generous vacation package and sick leave Production Bonus Very flexible and family friendly hours Generous Matching 401K plans About Us: MR of Sioux Falls, LLP is a full service staffing company that will assist you with both professional permanent placement as well as interim placement. Our 16+ years of service and reputation have allowed us to become recognized as a LEADER within the world???s largest network of executive search professionals, comprised of over 1,000 offices and 3,500 professional recruiters, by achieving the International #1 TEAM for last two consecutive years. We are looking for outstanding Healthcare professionals who pride themselves on their integrity, reputation and work history as ???THE top performers??? in their respected industries. We work with these top caliber professionals to confidentially prospect and pursue their next outstanding opportunity in their career. For more information about our company please visit our website at www.agoodjob.com

Job Title: Manager, Regulatory Affairs Company: Location: Carlsbad, CA Description: New Requisition Initiation Form ________ Req# PART I: HIRING MANAGER Business Card Title: Manager, Regulatory Affairs Posting Type: External Budgeted or Non-budgeted: Budgeted Reason for Opening: New Replacement For: TASKA and REACH are regulations we need to be in compliance with and do not currently have a resource to do this. Full Time / Part Time: Full Time Employee Type: Regular Number of Openings: 1 Department Name: Operations/Quality Cost Center: 10048002 Hiring Manager: Mark Stavro Next Level Manager: Ghazi Kashmolah HR Generalist: Uma Hoffman Next Level HR Generalist: Finance Approval Contact: Primary Work Location: Carlsbad, California, U.S.A. Number of Direct Reports: 0 Percentage Travel Required: 10 Has an internal employee or conversion already been identified?: No (If “Yes”, this position will not be sourced externally, and there will be no fee for internal or a 5% fee for conversion. If “No”, this position will be sourced externally and will incur an 18% recruiting fee.) PART II: RECRUITER Position Title (HR System Title): Manager, Reg Affairs Jobcode: QU29US Career Band: M-1 Salary Range: 83,500-93,572 Variable Compensation (ICP or Sales Comp): 10 Sign-On Bonus Amount: 7,500-10,000 Relocation Eligible: NOT ELIGIBLE Shift: First Recruiter: M. Harper Co-Recruiter: % Charge: 18% Standard Confidential: NO Pure Science. It is the heart of our organization and the DNA of the people who make a career at Invitrogen. Each day, we put the vast potential of biology into action, devising technologies and providing services critical to life science research as well as drug discovery, development and production. Our labs and offices are infused with entrepreneurial energy and intellectual curiosity that foster questions and answers that produce real-world results in laboratories across the globe. In fact, many of the greatest medical discoveries of the last two decades were made using Invitrogen products, including the discovery of the AIDS virus, advancements in cancer treatment, and the development of tools to assist in stem cell research. If you too have a passion for science and the business of biotech, please consider this opportunity: Invitrogen is seeking a Manager of Regulatory Affairs to support U.S. TSCA (Toxic Substances Control Act) and European REACH (Registration, Evaluation and Assessment of Chemicals) regulations. This position is the primary regulatory liaison/representative for Global TSCA and REACH compliance, and serves as the primary contact with TSCA and REACH regulatory authorities. This position reports to the Director of Global Regulatory Affairs, Invitrogen Carlsbad, California, U.S.A. ? Global responsibility for Toxic Substances Control Act (TSCA) compliance, including systems for: TSCA inventory, import and export certifications, Pre-Manufacture Notices, Commencement of Manufacture Notices and 8(c)/(e) health effect allegations. ? Global responsibility for other initiatives include the Registration, Evaluation and Assessment of Chemicals (REACH) in Europe. Also responsible for systems to address similar regulations in other regions/countries. ? Create and manage a global TSCA and REACH program at Invitrogen – internal education, communication, and self-auditing. ? Set up global SOP’s for addressing TSCA and REACH. Essential Functions: • Carries out responsibilities in accordance with Invitrogen’s policies, procedures, and state, federal and local laws, including safety rules and regulations. • Track legislative and regulatory proposals in the areas of chemical management policy, and general chemical risk. • Develop TSCA and REACH expertise that will position you as an invaluable technical resource for other employees. • Develop contacts with regulatory agencies. • Participate in internal company regulatory/quality audits. • Provide internal training on TSCA and REACH. Experience requirements: • Working knowledge of the Toxic Substances Control Act (TSCA). • Working knowledge of REACH (Registration, Evaluation and Assessment of Chemicals). • Understanding of the U.S. In-Vitro Diagnostic/Medical Device regulatory affairs and European IVD Directive: Regulations, Submissions, Technical Files, cGMP/Quality Systems, Compliance and Import/Export regulations. • Direct and positive experience in communicating with Regulatory Authorities. • Multi-site experience, in a mid to large size company; experience in building global systems. • Global/International experience and background. • Experience with common continuous improvement tools a plus (e.g., six sigma, SPC). • Business and personal computer hardware and software applications. • Business English usage, spelling, grammar and punctuation in order to convey information in a logical and concise manner to colleagues. • Supervision and training practices and methods. • Ensuring that information provided is accurate and complete. Desired Profile: • Should be at ease with direct communication with internal teams and external regulatory agencies, distributors and customers. • Should be organized, able to work to on multiple projects, with tight deadlines. • Willing to travel away from home on an occasional basis (10-15%). • Demonstrated leadership skills and experience in managing change, influencing outside of his/her area of responsibility, attracting/developing talent, and coupling high performance standards with appropriate soft skills • High energy level; positive attitude; works well under stress; strong communicator. • Balance of strategic thinking, analytical skill and ability to execute. • Hands-on, action-oriented, and able to implement effectively. • Cost-effectiveness and continuous improvement minded. • Able to work autonomously in a matrix-managed organization. • Able to make these decisions without excessive use of consultants. • Comfortable with ambiguity and change. • Cultural fit with Invitrogen culture: “down to earth” personality, approachable, friendly with people at all levels and in all cultures, informal, unquestioned integrity, honesty, and a good sense of humor; hard-working and intense; open, collaborative management style that fosters the development of key talent and leaders. • Good business sense for what’s practical, and what’s not, what’s needed for what parts of the business. Educational requirements: • Bachelor of Science Degree from an accredited college or university and a minimum of five (5) years of Regulatory Affairs in EH&S or Medical Device or In-Vitro Diagnostic, or Pharmaceutical technical work experience, or an equivalent combination of education and experience. We are proud to be an Affirmative Action / Equal Opportunity Employer committed to hiring a diverse and inclusive workforce.

Job Title: Regulatory Affairs, Managers and Specialists Company: The Merwin Group Location: Boston, MA Description: At Management Recruiters International— MRIN etwork, we specialize in the placement of outstanding talent in the medical device industry, combining a proven, targeted methodology and individual industry expertise to match outstanding candidates with the right opportunities at leading organizations. Our client is a global medical device company, a pioneer for advanced neuroscience therapies for the treatment of central nervous system disorders. The Regulatory Affairs Manager and Specialist opportunities are best suited for an individual with extensive technical regulatory knowledge, Class II – III experience, multi-taskers who can work with a vast variety of medical devices. If you are motivated for a challenging and rewarding opportunity, we would like to assist in determining if this opportunity or many of our other searches match with your expectations, background and experience Essential Duties & Responsibilities Coordinate preparation/preparation of US and International regulatory submissions, including 510(k), IDE, PMA Supplements, Design Dossiers/Change Notifications, and Technical Files Devise strategic regulatory plans to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products (or as a specialist work with management to devise strategies to ensure rapid and timely approval of devices) Participate and provide guidance and support to the company’s management and product development teams Review and analyze ECOs, NCRs, special devices, labeling, manufacturing, marketing and clinical protocol procedures and documents Review and analyze technical data generated by Research and Development, Marketing/Sales, Clinical Research, Quality Assurance or other related departments Review, analyze and incorporate into submissions relevant clinical literature Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approvals in other countries, as well as provide routine regulatory information to associates and affiliates Interact with regulatory agencies and direct/expedite submissions through approval process

Job Title: Director, Regulatory Affairs Company: Location: Cheshire, CT Description: Reports to the Sr. Director, Regulatory Affairs. Is responsible for strategic definition/direction and implementation of all Cheshire based regulatory strategies, and ensures that these strategies are consistent with company objectives. Interacts with members of other departments/areas to plan, compile, write, modify, etc. documentation to be sent to FDA or other regulatory agencies, in support of (e.g.) IND, BLA, DMF, MAAs or other regulatory applications as needed. Leads all strategic liaison activities with US and Canadian Regulatory agencies. This position will be the primary point of contact with licensing/development partners for regulatory strategic matters. The incumbent will be responsible for the growth and adaptation of the Regulatory Affairs department to meet the needs of the company. Will represent the company as needed for regulatory affairs matters. Main Responsibilities Lead the Regulatory Affairs Department in the required regulatory related strategy for all research & development candidates and approved products, including line extensions. Participates in the development project teams to create and communicate regulatory strategy, and for strategic planning and submission of documentation to regulatory agencies as appropriate, such that development timelines and compliance with regulations can be maintained. Will be responsible for ensuring that Alexion is in compliance with regulatory requirements for all ongoing projects. Assures that the documentation being provided to regulatory authorities meets standards for completeness and compliance with regulations and company best practices. Ensures that communications with other groups (QA, QC, Manufacturing, Process Development, clinical, research, etc) to write and generate such documentation occurs and when necessary take the lead in generation / authoring of documents. Acts as the liaison within Alexion for information requests to and from Regulatory agencies, and is responsible for tracking their progress. Acts as main Alexion contact for any contract manufacturers, licensers, consultants, etc. regarding timely writing and transfer of regulatory related documentation to/from Alexion. Will be the lead Regulatory member on project teams for new development candidates, and will participate in the strategy to develop product in a timely fashion, thus expediting generation of clinical supplies, process development and analytical development, in support of new INDs and first in human clinical studies. Visa Sponsorship Not Available for this Position Education Requirement: Skill Requirements Advanced degree or equivalent education in a science. M.S / PhD, R.Ph., Pharm D. (preferred). At least 10 years prior experience in Regulatory Affairs within the Pharmaceutical Industry, preferably biotech, or equivalent experience. Past experience with oncology and/or hematology research / development desirable. Proven experience in regulatory liaison activities with regulatory agencies, including prior achievement of product approvals, filing of INDs, NDAs, BLAs, MAAs, CTAs, CTXs, etc. Experience in several regulatory disciplines (e.g. clinical development, CMC, preclinical, advertising and promotion, pre and post-approval activities, product launches, etc.) would be a strong plus. Good oral and written communication skills. Ability to handle changing priorities and multidisciplinary tasks. Incumbent must possess sense of urgency, people skills and be able to thrive in a team oriented, visible small company environment. Self motivation, team sprit and open communication are essential. Notes: Alexion Pharmaceuticals is a publicly traded company engaged in the development of novel drugs for the treatment of hematologic disorders, autoimmune diseases, cardiovascular disorders and cancer. Alexion offers a highly competitive package of base and incentive compensation, group healthcare coverage, tuition reimbursement, relocation assistance, a 401(K) plan and stock options. Alexion is an Equal Opportunity/Affirmative Action Employer. Principals only, no agency calls