SENIOR MANAGER REGULATORY AFFAIRS
Full Time • Princeton
SUMMARY OF POSITION
The Sr. Manager, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines and federal regulations governing pharmaceutical drug development to all aspects of Our Client’s ’s drug development programs, policies and procedures; ensuring a compliant state of regulatory commitment. Ensures that appropriate CMC regulatory activities occur in support of both pre and post-approval submissions while meeting aggressive timelines and adhering to the highest quality standards. Works on and solves increasingly complex projects/problems where analysis of the situation or data requires evaluation of some intangible factors. Ensures that regulatory files and data systems are maintained and in compliance with related work instructions and regulations.Collaborates with functional groups to plan, author, compile and submit high-quality original applications, amendments, supplements and responses to inquiries from FDA.
RESPONSIBILITIES
Primary responsibilities of this role include the following: 15. Manages all regulatory activities associated with Our Client’s development projects, as assigned. 16. Participates in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals for assigned projects. 17. Provides guidance to multidisciplinary teams on the content, format, style and architecture of US submissions for assigned submissions. 18. Critically reviews documentation intended for submission to the FDA for internal consistency, for consistency to relevant FDA guidelines and to promote regulatory excellence.
19. Manages the organization, preparation and review of new ANDAs, amendments, supplements, annual reports and other regulatory documents and correspondence, as assigned. 20. Performs and manages critical analyses of data and independently develops interpretations and conclusions for discussion/consideration with regulatory management. 21. Ensures the completeness and accuracy of all assigned regulatory submissions. 22. Responsibility for the planning, preparation and submission of regulatory documentation according to planned timing.
QUALIFICATIONS
Advanced degree in a life science. Minimum of 10 years of pharmaceutical industry experience, at 8+ years in Regulatory Affairs with emphasis on CMC. Must have managerial experience.
Exhibits excellent written, verbal and negotiation skills. Must be able to effective articulate complex project related matters.
Advanced understanding of pharmaceutical development and CMC regulatory affairs including regulatory guidelines, federal regulations and legal considerations.
Strong ability to prioritize, multi-task and work in a very fast paced and dynamic environment.
Strong critical and logical thinker with ability to analyze problems.
Highly organized and self-motivated. Demonstrated successes at developing fully functional regulatory teams.
Able to exercise sound judgement. Demonstrated ability to make sound decisions on regulatory activities, strategies and work outputs.
Unyielding predisposition to detail, accuracy and clarity.
The Sr. Manager, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines and federal regulations governing pharmaceutical drug development to all aspects of Our Client’s ’s drug development programs, policies and procedures; ensuring a compliant state of regulatory commitment. Ensures that appropriate CMC regulatory activities occur in support of both pre and post-approval submissions while meeting aggressive timelines and adhering to the highest quality standards. Works on and solves increasingly complex projects/problems where analysis of the situation or data requires evaluation of some intangible factors. Ensures that regulatory files and data systems are maintained and in compliance with related work instructions and regulations.Collaborates with functional groups to plan, author, compile and submit high-quality original applications, amendments, supplements and responses to inquiries from FDA.
RESPONSIBILITIES
Primary responsibilities of this role include the following: 15. Manages all regulatory activities associated with Our Client’s development projects, as assigned. 16. Participates in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals for assigned projects. 17. Provides guidance to multidisciplinary teams on the content, format, style and architecture of US submissions for assigned submissions. 18. Critically reviews documentation intended for submission to the FDA for internal consistency, for consistency to relevant FDA guidelines and to promote regulatory excellence.
19. Manages the organization, preparation and review of new ANDAs, amendments, supplements, annual reports and other regulatory documents and correspondence, as assigned. 20. Performs and manages critical analyses of data and independently develops interpretations and conclusions for discussion/consideration with regulatory management. 21. Ensures the completeness and accuracy of all assigned regulatory submissions. 22. Responsibility for the planning, preparation and submission of regulatory documentation according to planned timing.
QUALIFICATIONS
Advanced degree in a life science. Minimum of 10 years of pharmaceutical industry experience, at 8+ years in Regulatory Affairs with emphasis on CMC. Must have managerial experience.
Exhibits excellent written, verbal and negotiation skills. Must be able to effective articulate complex project related matters.
Advanced understanding of pharmaceutical development and CMC regulatory affairs including regulatory guidelines, federal regulations and legal considerations.
Strong ability to prioritize, multi-task and work in a very fast paced and dynamic environment.
Strong critical and logical thinker with ability to analyze problems.
Highly organized and self-motivated. Demonstrated successes at developing fully functional regulatory teams.
Able to exercise sound judgement. Demonstrated ability to make sound decisions on regulatory activities, strategies and work outputs.
Unyielding predisposition to detail, accuracy and clarity.
Compensation: $80,000.00 - $170,000.00 per year
TK-CHAIN® is a Lifesciences Consulting and Staffing Solutions company, helping pharmaceutical, biotechnology, medical devices, and clinical research companies streamline processes in drug and vaccine discovery, through proprietary systems, processes, and methodologies, TK-CHAIN® can map key customer problems, and offer customized solutions. Since the company began operations, it has enforced a performance-driven, and results-oriented culture, making it a reliable, and widely acclaimed partner for high-profile R & D client projects.
For more than 35 years of combined experience, companies have turned to TK-CHAIN for the highest caliber of talent solutions, knowing that we have an extensive network of global seasoned consultants that can be trusted to get the job done.
That’s because we know our consultants and the industries we serve. We constantly build new relationships through personal referrals and references to ensure the best and brightest minds are part of our TK-CHAIN talent network.
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