Director Of Regulatory Affairs Jobs in Massachusetts

Job Title: Associate Director Regulatory Affairs Company: Genzyme Location: Cambridge, MA Description: Genzyme Corporation, ranked as one of the foremost biotechnology companies in the world, is committed to providing an exceptional environment in which individuals can excel, and achieve their professional and personal goals. Genzymes people and culture have been consistently recognized for excellence. For example, we have been named several times to Fortunes list of the 100 Best Companies to Work For in the United States. We also consistently rank among the top employers for scientists in surveys of Science readers. Genzymes local offices and facilities in Europe and other parts of the world have earned similar distinction as respected employers. By applying for a position with Genzyme, you are taking the first step toward becoming a part of our dynamic and talented team, and sharing in our continued success.The Associate Director, Regulatory Affairs will provide leadership and direction for global regulatory strategies for the Gaucher franchise within the LSD/Therapeutics Business Unit. The products within this area include Ceredase, Cerezyme and a new, promising small molecule candidate. Cerezyme is one of the greatest current revenue drivers for the corporation. The appropriate candidate will work with the Gaucher project team to develop an aggressive development path for the small molecule product. He/She will interact with FDA and other regulatory authorities on new product development, marketing applications, label changes and post approval issues.The candidate will work to develop long and short-term regulatory strategies and provide direction to the project team and direct reports for the successful regulatory approval of the Gaucher Disease small molecule. They will work with senior management and the business unit to construct world wide regulatory strategies and achieve product development goals. In addition, he/she will maintain approvals by ensuring compliance with legal requirements and post-approval changes required. Communication skills will be critical to the success of the candidate in this position. Communication with senior management, regulatory staff, and functional groups such as RD, Manufacturing, Clinical, Quality and business partners will be essential.Job Responsibilities: Provide regulatory leadership in support of the development and registration of products under responsibility Oversee the development and implementation of short and long term regulatory strategies in support of project objectives for assigned products Develop and monitor budget plans for assigned programs and seek agreement with business units on regulatory support requirements Provide input into departmental budget Manage direct reports to achieve goals related to regulatory schedules, processes, and methods Ensure continued professional development of staff Assess the accuracy and appropriateness of submission to regulatory authorities to support successful Clinical Trial Applications and/or Marketing Authorizations Advise staff, management and team members of major regulatory issues and actively contribute to their management Assist in the review and clearance of external communications for assigned programs Keep abreast of changes in the regulatory environment and implement necessary adaptations Provide input into Standard Operating Procedures, protocols and reports Represent the company to outside customers and vendors Provide regulatory due diligence assessments of new business opportunities as requiredIn addition to the above, when assigned as global product lead for Regulatory Affairs for a given program the incumbent is responsible for: obtaining world-wide input into the global regulatory strategy owning and clearly presenting the global regulatory strategy for appropriate development and optimized approval chances leading the global regulatory team in implementing the regulatory strategy to achieve timely filing and approval of new products in accordance with business objectives maintaining a high level of understanding of global regulatory requirements

Job Title: Director of Regulatory Affairs Advertising and Promotional Review Company: MRINetwork Location: Princeton, MA Description: Director of Regulatory Affairs Advertising and Promotional ReviewOur client, located in the Boston, MA area, is a biotech organization focusing on drug discovery, development and commercialization.  They are experiencing significant growth and looking to add a key member to the regulatory affairs group.  If you are a regulatory advertising and promotional professional looking for your next challenge, this could be the place for you.Job Responsibilities:Establish and manage the advertising and promotional functions within the organization Responsible for directing post-marketing regulatory activities.Interact with DDMAC routinely and regulatory agencies on post-marketing subject matter. Provide regulatory, operational, and management expertise for post-marketing activities. Knowledge of pre-marketing regulations and able to provide support on ongoing pharmaceutical development programs. Assist in the marketing of regulatory strategy and manages the regulatory aspects of the program and people contributing to the program. Provide regulatory oversight in the development, review, and approval of presentations and materials to be used by medical liaisons and other scientific staff. Responsible for professional development of regulatory staff.Job Requirements:B.S./M.S. in Life Science (PharmD preferred) with a minimum of five to eight (5-8) years regulatory affairs experience. Prior regulatory experience with US labeling, promotion and advertising reviews, strategy for marketed products, and interaction with DDMAC required. In depth understanding of regulatory processes, procedures, guidelines and regulations Must be able to function as the regulatory expert on post-marketing, advertising and promotion Good understanding of the drug development process Experienced in presenting information at internal and external meetings.Compensation:$157,000.00 (compensation commensurate with experience and salary history) Comprehensive benefits package and relocation assistance.For confidential consideration, please forward your resume in a Word document to Register to View  Only qualified candidates will be contacted.Visit www.kleinhersh.com to view other job opportunities available through our company.

Job Title: Associate Director, Regulatory Affairs Company: Biogen Idec Inc Location: Cambridge, MA Description: This position is in the Regulatory CMC group and is focused on the development of small molecules, specifically, BG-12 and other late stage programs. Responsibilities include actively contributing to the development and implementation of CMC regulatory strategy for specific small molecule projects including identifying and assessing regulatory risks, implementing NDA/MAA filing readiness strategy, developing pre-NDA/MAA agency meeting strategies, serving as the regulatory representative on project teams, serving as the regulatory contact with relevant regulatory authorities, and coordinating all CMC aspects of regulatory submissions.Qualifications Minimum 8+ years pharmaceutical/biotechnology industry experience, 4 years regulatory experience working on small molecule programs. Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals. Demonstrate excellent communication skills. Ability to represent the department in project teams. Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload. Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff. Experience in interfacing with relevant regulatory authorities. Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements. Knowledge and understanding of applicable regulations. Computer literate.EducationBA/BS/University degree required, Life/Health Sciences preferred

Job Title: Manager of Regulatory Affairs Company: Randstad Location: Cambridge, MA Description: This individual is expected to provide leadership within Regulatory Affairs and will be responsible for actively contributing to the development and implementation of CMC regulatory strategy for large molecule products in development as well as coordinating all aspects of CMC regulatory submissions relevant to their assigned projects or programs. This person will serve as the regulatory CMC representative on relevant project teams, and as the regulatory CMC contact with FDA. DUTIES & RESPONSIBILITIES Develop global CMC regulatory strategy for development products. Direct management of assigned large molecule development programs. Drive all CMC submission activities (IND, CTA, NDA, BLA) and health authority interactions (meeting requests and briefing documents). Represent Regulatory Affairs at various project team and working group meetings. Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines. Expected to develop and manage project timelines as well as have the ability to multi-task. Monitor changes to development plans and provide regulatory guidance to teams to bridge changes into the clinic. Contribute to the development of comparability protocols, validation protocols, and stability protocols. Ensure the quality and content of all submissions to health authorities. Liaise with partnering companies to ensure regulatory alliance. Act as direct point of contact with FDA and other regulatory authorities for CMC related issues. Mentor and coach junior regulatory staff and other team members. Working hours: 8:30-5:30 (M-F) QUALIFICATIONS Basic Qualifications: Position requires a minimum 4-year degree in Chemistry, Biochemistry, Molecular Biology, Biology or related field; advanced degree helpful. Must have a minimum of 5 years experience in Regulatory Affairs or equivalent experience within the pharmaceutical industry. Previous experience in leading submission teams for marketing application and/or clinical trial applications and direct experience in interacting with regulatory authorities is also required. Preferred Qualifications: Must demonstrate a solid working knowledge of drug development process and knowledge of FDA regulatory requirements; EU, Canada, and ROW experience highly desirable. Candidates must be able demonstrate strong project management, problem-solving, negotiating, interpersonal and communication skills (both written and oral). Years Experience 3-5 Years Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad.

Job Title: Senior Regulatory Affairs Manager Company: MRINetwork Location: Boston, MA Description: Senior Regulatory Affairs Manager My client is a new, start-up medical device company to start building their Regulatory Affairs team. The Regulatory Affairs Sr. Manager will have responsibility for filing their lead device's 510(k) and maintaining the organization's quality systems. This is an exciting opportunity to join a small organization that gives you the ability to make an immediate impact. If you are an ambitious Regulatory Affairs professional looking for the next step in your career, this may be the place for you. Job Responsibilities: Prepare regulatory submissions (510(k), PMA) to secure FDA marketing clearance. Develop regulatory assessments and strategies in support of the company's business activities. Prepare / coordinate regulatory submissions for all areas of the world Educate the organization on and review and approve of regulatory aspects of product labeling. Monitor changes to domestic and international regulations and standards. Insure company compliance to all applicable regulations and standards Assess and maintain the company's Quality System Job Requirements: B.S. in Scientific or Technical discipline Minimum 10 years experience in Medical Device industry Minimum 5 yeas experience in Regulatory Affairs Strong working knowledge of QSRs and other applicable FDA regulations; specifically Design Controls Experience working in an FDA-regulated environment for software controlled electromechanical devices or sterile disposables Experience with ISO9001, ISO 13485, CE marking requirements, and MDD Experience with General Principles of Software Validation and ISO14071, and Risk Management ISO14971 Demonstrated high performance orientation, detail orientation, and market knowledge Excellent written, listening, and verbal communication skills For confidential consideration, please forward your resume in a Word document to Register to View only qualified candidates will be contacted. Visit www.kleinhersh.com to view other job opportunities available through our company.

Job Title: Director Regulatory Affairs Company: Novartis Corporation Location: Cambridge, MA Description: The Director of Regulatory Affairs provides direct regulatory support for multiple diagnostic projects within in the Novartis Molecular Diagnostic unit. Develops and implements regulatory strategy for both companion diagnostics and standalone diagnostics. Lead program efforts relative to premarket submission, diagnostic partnering, FDA interface regulatory policy and practice. Facilitate integration of Dx regulatory strategy within the Drug/Diagnostic Co-development initiatives at Novartis. Self directed position with limited oversight for most assignments. Major Accountabilities (Describe the main results of the job to be achieved ) Ensure early diagnostic regulatory input around Proof of Concept and during clinical development to Technical and Clinical Development Teams for all diagnostic tests applicable to the Drug Development programs Implement the Regulatory Affairs vision for regulatory affairs for molecular diagnostics and the action roadmap for activities with the regulatory bodies beyond the actual programs to ensure Novartis' interests are reflected Collaborate closely with drug regulatory affairs for all companion diagnostic programs Provide input for all BD&L and M&A activities with respect to the regulatory risks and benefits of potential deals Provide training for key stakeholders internal and external of MDx (e.g. DRA in pharma) Represents the Diagnostic regulatory team internally and externally with objective advocacy of the projects pipeline potential as well as the overall regulatory perspective in diagnostic regu-latoryKey Performance Indicators (Indicate how performance will be measured: indicators, activities) ? Complete and timely submission of regulatory documents to authorities ? Successful negotiations of Novartis interests with regulatory bodies? Successfully broaden the regulatory knowledge within the MDx Leadership Team and Novartis Pharma? Standardized MDx regulatory policies and practicesMinimum requirementsAdvanced education degree in life-sciences, engineering or public health.1. Greater than 7 years work related profession experience. 2. 3+ years experience in drug/diagnostic regulatory affairs. 3. 5+ years multi/cross functional leadership experience in clinical development, preferably in molecular diagnostics4. Knowledge of drug development and regulation affairs requirements5. Familiar with regulatory issues and challenges associated with Drug/Diagnostic co-development and companion diagnostics.6. Have a track record in successful FDA and ROW premarket submissions and registrations7. Solid understanding of molecular technologies and the impact on outcomes and diagnostic results8. Leadership capabilities working across varied cultures, expertise and backgrounds9. Excellent negotiation skills with regulatory staff on various levels of hierarchy 10. Outstanding interpersonal and communication skills for bridging scientific and business participants, for negotiating timelines and for effective international collaboration.

Job Title: Sr Mgr, Regulatory Affairs Company: Millennium Pharmaceuticals, Inc. Location: Cambridge, MA Description: Company Information:Breakthrough Careers!A career at Millennium: The Takeda Oncology with something no other can offer: a of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality.Position Summary:This individual is responsible for actively contributing to the development and implementation of CMC regulatory strategy for small molecule products in development as well as coordinating all aspects of CMC regulatory submissions relevant to their assigned projects or programs. This person will serve as the regulatory CMC representative on relevant project teams, and as the regulatory CMC contact with the FDA.Duties and Responsibilities:Contribute to the development of global CMC regulatory strategy for products in development. Direct management of assigned small molecule development programs. Drive all CMC submission activities (IND, CTA, NDA, BLA) and health authority interactions (meeting requests and briefing documents). Represent Regulatory Affairs at various project team and working group meetings. Assess and CMC regulatory requirements to ensure all development activities are in with applicable regulations and guidelines. Develop and manage project timelines as well as have the ability to multi-task. Monitor changes to development plans and provide regulatory guidance to teams to bridge changes into the clinic. Contribute to the development of equivalency protocols, validation protocols, and stability protocols. Ensure the quality and content of all submissions to health authorities. Liaise with partnering to ensure regulatory alliance. Mentor and coach junior regulatory staff and other team members.Qualifications:Basic Qualifications: Position requires a minimum 4-year degree in Chemistry, Biochemistry, Molecular Biology, Biology or related field; advanced degree helpful. Must have a minimum of 4 years experience in Regulatory Affairs or equivalent experience within the pharmaceutical industry. Previous experience in leading submission teams for marketing application and/or clinical trial applications and direct experience in interacting with regulatory authorities is also required.Preferred Qualifications: Must demonstrate a solid working knowledge of drug development process and knowledge of US regulatory requirements; EU, Canada, and ROW experience highly desirable. Candidates must be able demonstrate strong project management, problem-solving, negotiating, interpersonal and skills (both written and oral).

Job Title: Director, Regulatory Affairs-CMC Company: BiogenIdec Location: Cambridge, MA Description: I. Position Summary: This position is responsible for leading a Regulatory CMC biologics team. Responsibilities include directing innovative CMC regulatory strategies for product development and approval; commercial product maintenance and life cycle development; responsible for regulatory documents, and submissions; represent the company with domestic regulatory authorities, contractors and corporate partners; provide regulatory support for various departments, projects, and teams/committees; and manage direct reports. II. Duties and Responsibilities: A. Essential Functions: y- Responsible for directing regulatory CMC strategies for biologic projects and programs. y- Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks. y- Provide regulatory guidance to company personnel throughout the research and development process. y- Direct the organization and preparation of clear and effective submissions. y- Prepare and deliver effective presentations for external and internal audiences. y- Monitor and analyze appropriate regulatory agency activities in areas of interest to the company. y- Develop and maintain highly capable and dedicated regulatory staff. Guide subordinates in carrying out responsibilities. Responsible for coordinating subordinate activities and career development. y- Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position. y- Provide leadership on project teams and subcommittees. y- Allocate representation on relevant project teams. y- Provide input to Regulatory Senior Management teams. y- Foster a global view as part of the whole regulatory team.y- 8 years pharmaceutical/biotechnology industry experience with technical management experience.y- Minimum of 6 years in RA.y- Good knowledge of applicable regulations.y- Experience in interpretation of regulations, guidelines, policy statements, etc.y- Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.y- Experience in interfacing with relevant regulatory authorities.y- Foster effective, positive interactions with regulatory agencies, and corporate partners.y- Ability to lead and influence project teams, committees, etc. to attain group goals.y- Demonstrate excellent leadership and communication skills.y- Ability to represent the department in project teams, committees and external meetings.y- Demonstrate strong organizational skills, including the ability to prioritize personal workload.y- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.y- Strong sensitivity for a multicultural/multinational environment. Experience leading multi-disciplinary teams.y- Well organized, detail oriented, effective written and oral communication skills.y- Supervisory experience.y- Ability to guide, train, supervise and prioritize workload of direct reports.y- Computer literate.y- Knowledge of local and international GMP requirements.y- Experience in assessing compliance of CMC documents with current Guidelines and Regulations. Capable of recommending strategies to achieve such compliance.y- Experience in assessing impact of proposed CMC changes to licenses or clinical trial applications.RJC:1066

Job Title: Associate Director, Regulatory Affairs Company: Shire Location: Lexington, MA Description: The Associate Director of CMC Regulatory Affairs, working in a growing dynamic company that continues to add new products to its pipeline while also expanding the reach of its 4 commercial products, must be capable of adapting to new situations and priorities. Intelligence, collaboration, excellent problem solving and communications abilities, and good relationship management are key traits for success. The Associate Director will serve as the global product leader for CMC regulatory strategy of one or more biological therapies. This will include formulating and implementing CMC regulatory strategies for activities in the US and Canada. Primary role includes: Serve as a liaison between the regulatory authorities and the company on CMC issues Provide CMC RA leadership within RA and on cross-functional Project and CMC teams Maintaining up-to-date knowledge and expertise of relevant FDA and ICH CMC guidelines and regulations. Responsibilities: Serve as a liaison with regulatory authorities for products in the area of Chemistry, Manufacturing and Controls Provide CMC regulatory strategy for proposed changes, new development efforts, content message points, or other related activities. Facilitating timely regulatory approvals of new drugs and life cycle activities by ensuring the quality and appropriateness of submission documents, maintaining regulatory compliance for marketed products Collaboratively lead other development functions to ensure timely preparation and submission of high quality CMC content for an IND, CTA, IMPD, BLA, MAA, NDA, and NDS and their amendments/supplements. Evaluation of manufacturing change controls, assessment of regulatory impact and supporting their implementation

Job Title: Manager, Regulatory Affairs Company: Biogen Idec Inc Location: Cambridge, MA Description: The Manager, Regulatory Labeling is responsible for strategy development and risk assessment of activities in support of labeling development. This person will integrate overall business objectives into departmental goals and actions while integrating into cross-functional teams that establish regulatory strategy for drafting global labeling. Within cross-functional teams, this person establishes regulatory strategy for developing core labeling documents. This position influences regulatory agencies, professional organization and other functional teams within Biogen Idec in matters related to labeling.Develop regulatory strategy and tactics for developing core labeling documents Establish innovative strategies for achieving regulatory compliance for labeling Establish parameters for labeling and influence teams to share a common visionStrategically assess labeling activities and influence cross-functional team decision making for these activitiesExecute effective decision-making, planning and project management in the development of labelingAt end of Phase 3 development, establish strategy for developing US labeling assuring cross-functional consensusQualifications4-6 years of Regulatory ExperienceMinimum 2 years ALP experienceExperience in interpretation of labeling regulationsExperience in interfacing with FDADemonstrate excellent leadership and communication skillsAbility to represent the department on cross-functional teamsAbility to build capability through coaching and mentoringEducationBS/BS University degree required. Life/Health sciences preferred