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.