Director Of Regulatory Affairs Jobs in Illinois

Job Title: Manager, Regulatory Affairs, Labeling Company: Sagent Pharmaceuticals Location: Schaumburg, IL Description: Basic Function: Responsible for designing product labels, coordinating labeling activities with our partners and supporting the promotional material process. Major Duties and - Review and prepare labeling to ensure regulatory requirements are met for labeling at various stages in the submission lifecycle, from submission to post-market changes. - Independently manage all aspects of labeling and packaging activities between Sagent and partners to ensure labeling is compliant with the regulations and ready for product launch. - Proofread label copy. - Coordinate and provide oversight for the following processes: barcode and NDC assignment processes, SPL, Drug Listing, Label Master Index, Labeling Change Controls. - Review promotional material for compliance to applicable regulations and submit to DDMAC. Education/ Work Experience: -Bachelors degree required. -Minimum 5 years experience in pharmaceutical labeling. -Must have demonstrated project management experience -Candidate must have expertise in pharmaceutical labeling regulations, pharmaceutical promotional and advertising regulations, and cGMP. -Regulatory submission experience and 510K labeling /promotional/advertising experience is preferred. -Candidate must also be able to manage details, as well as, the big picture to ensure projects are completed accurately and on-time. Travel: Less than 10 travel. Reference : Letter Required Contract type : Full Time Job(s) available : 1 Experience required : 5+ Years Studies level required : Bachelors Degree Working place : Schaumburg, Illinois Creation date : 06/02/2010.

Job Title: GLOBAL REGULATORY AFFAIRS MANAGER Company: Abbott Laboratories Location: Des Plaines, IL Description: Manage Regulatory department functions, including US and international submissions (device IVD products, instruments, facilities, equipment and utilities, and Medical Devices), interactions with government agencies which may include US FDA and international regulating bodies, routine administrative registrations and international product registration and re-registrations. Support product development teams, factory/business teams, marketing, and compliance assurance which may include cGMP, ISO, Canadian MDR, r-PAL, and other ex-US government Quality Systems requirements. Responsible for making decisions on import and export requirements for devices. Assist management in developing strategies for rapid product approval and timely market entry, and for rapid approval for design changes to on market products.MAJOR Responsible for implementing and maintaining the effectiveness of the quality system.Responsible for implementing and maintaining the effectiveness of the quality system.Provides regulatory direction to technical staff engaged in process or product development or ongoing regulatory product support and improvement.Review practices and project plans for compliance to submission, government requirements and regulatory standards. Ensure alignment with current regulatory strategy. Formulate sound regulatory strategies to expedite licensing and registration of AM products worldwide. Manage area consistent with business goals. Develop procedures to implement division regulatory strategy. Ensure flow of effective communication is not interrupted.Manage and contribute to the development of appropriate regulatory strategies based upon thorough knowledge of government regulations. Provide advice and counsel to staff to resolve issues where few precedents exist; recognize and removes barriers to project or task completion.Direct the analysis of the impact of cumulative and annual product changes to the current product submissions and report to government agencies as appropriateIdentifies regulatory synergies for launch activities for worldwide products.ACCOUNTABILITY / SCOPE:Manage personnel providing support to product and/or functions.Advise project or group regarding regulatory strategies; may modify project or group priorities based on business strategy, regulatory requirements or input from senior managers.Assure government submissions meet regulatory expectations.Approver authority for change control, non-conformance, and risk evaluations.Release authority for labeling/sales/promotional materials.Official correspondent representing Abbott Laboratories. Approve use of manufacturing areas; equipment and systems for all product manufacturing.Analyze and prioritize needs for the budget. Spending authority is limited; proposals for additional funds are closely reviewed.Active participation and regulatory support on projects and activities may extend to larger organizational units, customers, and professional organization, to influence the decision.Accountable for achieving multi-million dollar sales through securing product approvals and providing evidence of compliance to all government requirements.Supervise exempt employees, contract workers, as appropriate.Complete performance reviews and assist with development planning for individuals within the group. Assure the unit goals and objectives are communicated.Present changing regulatory requirements and supports implementations into a positive division business strategy.Identify resource requirements needed to maintain regulatory support to changing business environment; assign resources to tasks, identify backups for staff positions, may propose succession plans for management review. Conduct interviews recommends candidates as openings occur.Build an affective team that contributes to a positive work environment; assess group performance.Reviews goal of staff, prepare own goals for review.Provide input to design of training programs for staff and division.

Job Title: Director of Regulatory Affairs Medical Device Company: MRINetwork - External Recruitment Location: Chicago, IL Description: Director of Regulatory Affairs Medical Device Our client is a publicly traded company that has been described recently by several prominent medical publications as "cash rich". They are expanding facilities, product lines, and business units in times when most companies are status quo. If you're looking for stability in an organization and a place where you can affect the lives of millions across the globe then this is your company. Responsibilities: Development and implementation of best practices within Regulatory Affairs. Assess technical strength and thoroughness of 510(k)'s and other document packages. Lead staff in international submissions and approvals necessary to market products both domestically and globally. Review approved labeling, promotional (advertising), and sales materials to ensure instructions for use are accurate. Partner with Quality team to ensure FDA compliance in all capacities. Participate in cGMP audits. Manage staff assigned to the department to ensure proper knowledge, training, and guidance are in place to perform at a high level.

Job Title: Regulatory Affairs Manager Company: Compliance Team Inc Location: Palatine, IL Description: Enhance your career by putting your valuable experience to work in a great team environment while contributing to the success of major biotech, pharmaceutical and medical device companies. Compliance Team, Inc. is seeking an experienced Regulatory Affairs Manager for a client-company. Our client-company, located in the Illinois, is currently seeking talented, highly-motivated individuals for the full-time permanent position described below. The Regulatory Affairs Manager ensures and assists with compliance of government regulations; advise, instruct and recommend policies to ensure compliance. The Regulatory Affairs Manager responsibilities include: Provide leadership and strategic decision making Monitor and interpret Federal Register CFR and other sources that provide information on new laws about the Food, Drugs and Cosmetics industries Review and approve proposed label and trade dress copy for compliance; insure compliance with FDA and Fair Packaging and Labeling Act Register annually with the FDA as a drug manufacturer; list all products that fall into a drug category Check documents for compliance with state and federal law; verify accuracy Ensure regulatory compliance by helping develop comprehensive internal and external audit programs Acquires information on current and applicable regulations by reading trade journals and state correspondence, and the Federal Register; distributes information to plant staff Requirements: In addition to the responsibilities stated above, the position requires the following skills and experience: Bachelor's Degree preferably in Sciences Minimum of 6 years in Regulatory Affairs in the drug industry, with 3 years in a management role Ability to manage several projects simultaneously and coordinates with large numbers of business contacts Excellent written and oral communication and negotiation skills required. Self-direction and motivation required First hand experience with the FDA inspection procedures Compliance Team, Inc. provides validation services, compliance consulting services, and technical staffing services as a solution to support our pharmaceutical, biotech, and medical device clients permanent and temporary technical staffing needs. Please visit our web site at www.complianceteaminc.com. Employer Information: The client-company associated with this position will not receive your resume or be notified of your interest in this position without your prior approval. Please forward any inquiries or questions regarding this opportunity to Register to View . Contact Information: For consideration, please send an MS Word copy of your resume via email indicating the position of interest to Register to View .

Job Title: Associate Director, Regulatory Affairs Company: Astellas Location: Deerfield, IL Description: Title Associate Director, Regulatory Affairs Category Research and Development Description Astellas is the bright spot in the pharmaceutical industry not just because of what we do, but in the way we do it. If you are looking for a company where you can change a life, make a dream come true, and light the way for a better tomorrow, Astellas is the place where you can shine. We offer a different kind of work culture. A high standard of ethics is mandatory. Quality is our pledge. Diversity is valued. Individual initiative is rewarded. Astellas offers an environment where our employees can make a real difference. Come, shine with us! Astellas is announcing an Associate Director, Regulatory Affairs in our Deerfield, IL location. This position plays a key role in the regulatory affairs department. Independently responsible for multiple regulatory functions and can be a member of one of several regulatory groups. Responsible for developing regulatory strategy for new assignments outside of existing regulatory frameworks (e.g., NDA strategy/planning for NMEs), with management oversight; driving submission related activities and successfully executing regulatory strategies. Responsible for significant interactions outside the regulatory affairs department on complex issues and questions. Provides regulatory expertise in directing projects within assigned therapeutic areas including International Regulatory Support, Clinical Research and Development, Chemistry Manufacturing and Controls (CMC), Advertising/Labeling, Regulatory Operations and to the Global Project Team. Serves on increasingly more significant project teams/task forces. Also responsible for the coordination/training of regulatory staff as appropriate. POSITION DUTIES: Actively seeks out knowledge of overall corporate strategy and other general factors that affect the regulatory positions taken within the company, and with the FDA and global health authorities, and incorporates this knowledge in interactions with others. Will also impact corporate strategy directly by participating in global strategic planning within therapeutic area project teams. Provides regulatory expertise for New Product Planning and Licensing due diligence activities. Member of important project teams/task forces requiring the interpretation of applicable FDA/ICH regulations to ensure compliance. Sets direction for key operations and new initiatives. Works closely with other individuals/groups within Regulatory Affairs to influence others to ensure departmental consistency, and identifies options for risk discussions. Oversees submissions and compiles complex, strategic submissions for assigned projects. Ensures that the compilation and transmission of submissions are within the defined time schedules and meet established standards and SOPs. Reviews regulatory submissions for accuracy, consistency and quality. Is considered a regulatory expert by global project teams/task forces and is accountable for developing and recommending regulatory strategy. Recognized as a person to whom others within the organization can consult to obtain answers to complex questions regarding FDA regulations and guidances. Manages the preparation and review of registration packages to ensure effective data presentation and quality scientific data against regulatory requirements. Independently manages complex technical documents for preparation, review and submission to regulatory agencies. Independently determines the best way to position information in assigned regulatory submissions to maximize FDA reviewability. Prepares and reviews summary tables of data from research and manufacturing reports, without direct supervision. Interacts with FDA and global health authorities on project related communications, including facilitating Divisional and committee meetings such as Pre-IND, IND, Pre-NDA, and NDA meetings. Interacts with other companies such as contract manufacturers, external development partners, and other subsidiaries such as APCA, API and APERD. Defines and implements regulatory strategies and priorities, including original NDAs. Revises regulatory strategy as necessary based upon scientific data, changes in the regulatory environment, global project direction, etc. Assists with ongoing training of Regulatory Affairs staff. Recognized as a person to whom others within the organization can consult to obtain answers to complex questions regarding FDA regulations and guidelines. Scope: Interacts with executive level on routine and serious matters; internally and externally to influence policy and strategy; with development partners, including negotiations on controversial areas. Establishes rapport with regulatory authorities that enables constructive exploratory discussions. Functions as the facilitator in FDA meetings. Impacts the company's overall success including overall sales and risk management. Failure to perform functions could result in significant regulatory compliance and credibility issues. Challenges: Works on strategic, complex and diverse problems with decision making that has functional or corporate impact. Actions may have serious implications on operations, revenue, and/or credibility. Position must anticipate regulatory issues for assigned projects and manage them proactively. Incorporate overall corporate strategy into interactions within Regulatory Affairs, with the FDA, with other global Regulatory Agencies and with external development partners. SUPERVISORY RESPONSIBILITY: Plays key role in selection, supervising, and ongoing training of Regulatory Affairs staff. Position Requirements KNOWLEDGE & EXPERIENCE: Bachelor's degree in scientific discipline; advanced degree preferred. 9 years previous pharmaceutical drug development experience, 2 in managing staff. Recognized as an expert in regulatory aspects of pharmaceutical drug development involving undefined frameworks with technical complexity and broad scope. Scientific knowledge in chemistry, general biological/physical science and ability to apply that knowledge to regulatory issues and product development. Recognized as an expert in an aspect of pharmaceutical drug development. 6 years regulatory affairs experience preferably involving direct contact with the FDA; full knowledge of FDA and ICH regulations and guidelines, and the ability to provide interpretations of that information to others. Proven record of successful IND/NDA submissions and negotiations with the FDA in areas of CMC and product formulations. Regulatory experience in other therapeutic areas such as medical devices or biologics. Strong organizational skills with the ability to manage large projects and provide regulatory guidance/training to direct reports and others in the department as needed. Proven ability to prioritize and multi-task with minimal supervision based on interactions with project team members. Ability to communicate effectively and maintain effective working relationships. Must be able to positively influence department staff and other APGD groups. High integrity with respect to maintenance of proprietary, confidential information. Excellent written and oral communication skills, with writing ability to meet regulatory requirements and standards. This position is currently accepting applications.

Job Title: Manager Regulatory Affairs Company: Cambridge Group, a part of On Assignment Location: Northbrook, IL Description: Manager Regulatory AffairsThe Manager Regulatory Affairs will develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations. The candidate will represent or lead the RA function on assigned cross-functional project teams. Monitor applicable regulatory requirements; assure compliance with company and external standards. Establish appropriate communication within RA and other functions primarily at project level. Perform gap analysis and propose solutions. Develop and document sound regulatory decisions and justifications. Ensure project teams and business objectives and deliverables are aligned with regulatory strategy. May provide direct supervision of individuals. May review promotional material or SOP's for compliance with local and global regulations. The incumbent must have sound basis of Regulatory knowledge. Documented 510(k) submission experience. Solid scientific knowledge. Ability to manage complex projects and timelines in a matrix team environment. Strong oral and written communication and presentation skills. Demonstrated interpersonal skills including strong negotiation skills. Ability to independently identify compliance risks and escalate when necessary. Ability to lead and coach others. A bachelor's degree or country equivalent in related scientific discipline with a minimum of 5 years regulatory experience in RA or related field, including managing people or projects. A higher degree/PhD will be an advantage. Up to 5% travel may be required.Please refer to job code SD7069 when responding to this ad.

Job Title: Regulatory Affairs Manager Company: Catalent Pharma Solutions Location: Chicago, IL Description: Regulatory Affairs ManagerJob Code :376Division :Catalent Pharma Solutions Sterile TechnologiesJob Title :Regulatory Affairs ManagerJob Type :Full-Time EmployeeShift/Hours :First Shift (Day)Location :Woodstock IL US 60098Category :Quality Assurance/Safety, LegalCareer Level :Manager/Director (Supervisor of Staff)Education :Bachelor's Degree% of Travel Required :0-10%Offer Relocation :NoJob Description :The Regulatory Affairs Manager is responsible for the overall development, implementation & adherence to the Annual Product Review & External Audit/Inspection Management Programs. In association with this authority, the management position is directly tasked with completion of Annual Product Reviews, maintenance of Customer Quality Agreements, oversight of State Licensing/Registration requirements & review of applicable Label Copy. This position leads regulatory submissions, regulatory registrations, communication of regulatory requirements, effective management of changes, participation jointly with client companies on new products/technical transfers, analyzing effects of trends of interpretation and enforcement of existing regulations, and defining potential impact of new regulations.The management position is directly tasked with review and approval of documents associated with the implementation of the programs detailed above, as well as identification and implementation of agency compliance initiatives while providing resources to investigate and mediate product complaints & support submission efforts to regulatory agencies. Performance of duties associated with the position requires extensive cooperation with Quality Assurance, Quality Control, Validation, Manufacturing, and Project Management.Specific Duties, Activities, and Responsibilities:Annual Product Review Responsible for the overall development & implementation of the Annual Product Review Program. Tasked with providing assurance that the overall program meets requirements as specified by applicable regulatory/authoritative bodies, as well as consistency with industry standard practice. Responsible for maintenance of a policy of continuous improvement, by way of consistently reviewing the Program against changing regulatory requirement, as well as for impact to the Facility s business need. Responsible identification of critical deliverables, and communication or management of these deliverables across the applicable functional areas of the Facility.External Audit/Inspection Management Responsible for the overall development & implementation of the External Audit/Inspection Management Program. Tasked with providing assurance that the overall program meets requirements as specified by applicable regulatory/authoritative bodies, as well as consistency with industry standard practice. Responsible for maintenance of a policy of continuous improvement, by way of consistently reviewing the Program against changing regulatory requirement, as well as for impact to the Facility s business need. Responsible for the response to regulatory agency communications as requested by the Director of Regulatory Affairs. Responsible for the generation of Standard Operating Procedures, Technical Position Papers & review of product labeling to ensure alignment with regulatory agency requirements.Submission Assists the Leader of Regulatory Affairs in the preparation and execution of regulatory submission strategy. Assist clients in the preparation of regulatory submissions. Authors, monitors & provides oversight to regulatory product schedules pertaining to CMC documentation associated with clinical trial applications & marketing authorization applications. Responsible for maintenance of documentation library in support of Customer submission/filing amendments, supplements & annual reports.Licensing/Registration Acts as the primary liaison with State & Federal regulatory bodies, as well as customers during audit or assessment of operations occurring within the Facility. Ensure that proper registrations are current and appropriate. Responsible for the proper identification of required licenses, as well as attainment of applicable licenses, in order to support manufacturing and distribution operations of the Facility.Compliance Initiatives Responsible for the establishment of key performance indicators associated with the Regulatory Affairs Department, as well as monitoring & reporting of these indicators at the direction of the Director of Regulatory Affairs. Responsible for the investigation & mediation of product complaints.Additional Responsibilities Communicate with clients regarding changes to facilities, processes and procedures. Monitor regulatory agency actions, both in terms of published regulations and benchmarking of inspection trends with other companies. Represent company in industry meetings focusing on regulatory issues. Provide training strategy on regulatory subject matter for the facility. Maintain effectiveness of the Quality System. Other duties as assigned.Job Requirements :Position Requirements:Education or Equivalent: Bachelor s Degree in a technical field or equivalent work experienceExperience: Minimum of 5 years directly applicable experience in the industry or equivalent combination of education and experience 10+ years progressive experience in quality, preferably regulatory compliance within a pharmaceutical manufacturing operation. 3+ years leadership experience Demonstrated knowledge of industry related Agency requirements Participation in FDA, customer, and/or other external auditsKnowledge/Skills Requirements: Demonstrated intermediate mathematical ability. High level of attention to detail. Strong communication skills both written and oral. A full complement of business computer literacy skills (e.g., word processing, spreadsheets, database software etc.) is preferred. Excellent problem solving and analytical skills. Works well under pressure and able to prioritize workloads. Must be able to interact effectively with a variety of individuals and personalities within and between departments. Review reports, etc. for accuracy and logic. Must be able to perform risk assessments in a timely manner and act accordingly. Demonstrate a bias toward action. Be willing to take a position, and assert influence to drive improvement. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to work independently on multiple projects. Be knowledgeable. Bring experience to the organization. Learn new skills; collect new information. Demonstrate a willingness to share skills and information with others. Demonstrate initiative. Develop ideas, and collect them from others. Continuously seek opportunity. Clarify issues, investigate Excellent documentation skills. Excellent problem solving and analytical skills. Make sound judgments. Meet deadlines and work under pressure with limited supervision. Possess and demonstrate excellent verbal, written and interpersonal communications skills. Should be familiar with cGMP and safe work practices. Works well in a team environment. Demonstrated ability to read, write, and speak clear English.Physical Requirements: Ability to stand for up to 4 hours per day Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, talking, writing, listening Occasional climbing ladders/steps, walking up inclines and uneven terrain, reaching with hands and arms, stooping, kneeling, crouching, crawling, twisting, bending, handling, turning, balancing, carrying, grasping Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 30 poundsBusiness Environment: Fast-paced Performance driven Customer focused Collaborative and inclusive