Associate Director / Director
Regulatory Affairs (Strategy)
Head of Regulatory Affairs
Paramus New Jersey
Regular, Full-time, Exempt
||The Associate Director/Director, Regulatory Affairs Strategy will be responsible for developing, implementing, and leading short and long term global regulatory strategies that support the success of investigational and marketed pharmaceutical products throughout their life cycle. The candidate will manage and lead all of the submission related activities associated with the US and ex-US (with the exception of Japan) fillings for product. The candidate will also ensure timelines are appropriately managed and kept to, and issues are appropriately raised and resolved in a timely manner.
|Essential Duties and
(Include but not limited to
Other duties may be assigned)
- Contributes to the development of global regulatory strategies
- Serves as primary liaison to FDA and provides strategic input with the regional regulatory leads responsible for ex-US regulatory activities.
- Interprets and communicates health authority correspondence effectively and quickly to senior leadership and clinical project teams.
- Partners with clinical project teams to assess regulatory support needs and aligns resources to provide regulatory support
- Identifies, monitors and resolves regulatory issues and reports progress to management
- Monitors regulatory submission activities and reviews regulatory documents prior to submission to ensure overall quality, compliance and timeliness
- Oversees planning and execution of major submissions and responses to regulatory authorities related to INDs, amendments, NDAs and supplements within company timelines and in accordance with regulations and guidelines
- Provide creative and innovative ideas to move the Global Regulatory Affairs department forward to address current and future challenges
- Relevant regulatory experience and strong emphasis in rare disease regulatory experience.
- Development and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document.
- Able to prioritize and work well in a fast-paced environment to multi-task, problem solve, and motivate and lead others.
- Able to present to senior leadership clearly, succinctly, with open-mindedness and willingness to defend difficult positions.
- Working knowledge of relevant drug laws, regulations and guidance's/guidelines.
- Strong sensitivity for a multicultural and multinational environment.
- BS/BA in Life Sciences in a relevant field with 8 or more years of broad pharmaceutical experience, including 5 or more years of new drug regulated product strategy/submissions; or Master's Degree with 6 or more years of pharmaceutical experience and 3 or more years of related Regulatory experience, including fellowship experience. Advance degree in PharmD or PhD in a relevant scientific discipline is a plus.
- Experience interacting with the FDA and ex-US health authorities (with the exception of Japan).
- Experience developing global regulatory strategies in coordination with clinical plans and marketing objectives.
- Experience in successfully leading teams and the ability to broadly represent GRA functions on project teams.
- Regulatory Affairs Certification a plus.