Senior Manager Regulatory Strategy
Company Summary:
My client, a biopharmaceutical company focusing on fighting rare diseases is looking to add a Regulatory Affairs Senior Manager to their team! This role will be hybrid based in Paramus, New Jersey requiring 2 days per week onsite.
This Regulatory Senior Manager will be responsible for:
- Serving as the liaison with the FDA and supporting and/or leading the planning and execution of global health authority interactions (briefing books, meeting preparations, etc)
- Providing strategic input with regional regulatory leads and support/guidance across all regulatory functions
- Assessing and communicating regulatory requirements to ensure compliance with guidelines
- Assisting and/or leading in major life-cycle management maintenance submissions and responses to regulatory authorities related to INDs, NDAs, amendments, and supplements within timelines and in accordance with regulations
This Regulatory Senior Manager should have the following qualifications:
- 5+ years of Regulatory experience in biotech/pharma industry
- 3+ years of new drug regulated product submissions and strategy experience
- Experience with rare disease/accelerated approvals is preferred
- Experience with labeling/global target labels is also a plus
