SUMMARY OF POSITION
The Director, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines and federal regulations governing pharmaceutical drug development to all aspects of Our Clients 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. Provides sound regulatory strategies in support of complex issues where analysis of de novo situations requires an evaluation of intangible factors. Continually monitors newly published FDA guidelines in the context of new and ongoing development programs and will provide training on applicable requirements for regulatory and scientific staff as required. Collaborates with functional groups to plan, author, compile and submit high-quality original applications, amendments, supplements and responses to inquiries from FDA.
ORGANIZATION STRUCTURE
The Director, Regulatory Affairs reports into the VP, Regulatory Affairs and is based in Pine Brook, New Jersey. Manages team of 2-5 direct and indirect reports.
RESPONSIBILITIES
Primary responsibilities of this role include the following: 1. Acts as liaison between company and FDA for assigned projects. 2. Manages all regulatory activities associated with Our Clients development projects. 3. Coaches & directs team to produce excellent work; provides development opportunities for team to reach their full potential. 4. Participates in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals. 5. Provides guidance to multidisciplinary teams on the content, format, style and architecture of US submissions. 6. Edits and manages the scientific sections of an application against the regulatory requirements. 7. Assists with the writing, review and preparation of more complex applications. 8. Manages the organization, preparation and review of new ANDAs, amendments, supplements, annual reports and other regulatory documents and correspondence. 9. Performs and manages critical analyses of data and independently develop interpretations and conclusions for discussion/consideration with regulatory management. 10. Performs critical reviews of all regulatory submissions, focusing attention on deficient/missing items/explanations. 11. Ensures the completeness and accuracy of all regulatory submissions. 12. Responsibility for the planning, preparation and submission of regulatory documentation according to planned timing. 13. Continually monitors newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs. Provide training on applicable requirements for regulatory and scientific staff as required. 14. Develops regulatory strategies for assigned projects by analysis of guidances and assessment of similar drug development scenarios.
QUALIFICATIONS
Advanced degree in a life science. Minimum of 12 years of pharmaceutical industry experience, at least 10 of those years in Regulatory Affairs. Must have at least 6 years of managerial experience.
Exhibits excellent written, verbal and negotiation skills. Must be able to effective articulate and negotiate complex project related matters to FDA.
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.