Senior Manager, Regulatory Affairs
A global biopharmaceutical company is looking for a Senior Manager, Regulatory Affairs to support the development, submission, and execution of regulatory strategies across multiple programs. This role will collaborate closely with product development teams to drive timely, compliant regulatory submissions and help advance key drug development initiatives.
Key Responsibilities
- Manage and support the preparation of U.S. regulatory submissions including INDs, NDAs, and BLAs, as well as ex‑U.S. submissions for assigned projects.
- Contribute to regulatory strategy by researching and interpreting global regulations and guidelines to ensure submissions meet regional requirements.
- Partner with Regulatory Operations to compile, prepare, and submit INDs, BLAs/NDAs, and other required filings.
- Support the Global Regulatory Lead (GRL) by coordinating defined deliverables, leading assigned workstreams, attending clinical study team meetings, and tracking submission status.
- Assist in the preparation and coordination of Health Authority meeting materials.
- Review, revise, and draft Standard Operating Procedures to ensure alignment with global regulations and guidance.
- Manage regulatory timelines, communicate risks, and ensure execution of regulatory strategy within approved schedules.
- Maintain up‑to‑date knowledge of FDA regulations and guidance related to INDs and BLAs/NDAs, while building familiarity with global regulatory frameworks.
- Perform additional duties as assigned.
Qualifications
- Bachelor's degree required; advanced degree (MS, PhD, PharmD) preferred.
- 5-8 years of regulatory strategy experience within the biotech or pharmaceutical industry.
- Strong ethical standards and attention to detail.
- Excellent organizational, communication, and presentation skills.
- Ability to work collaboratively across cross‑functional teams, both as a leader and a contributor.
- Strong interpersonal skills and the ability to maintain productive working relationships.
- Thorough knowledge of FDA regulations related to product development (IND) and marketing applications (BLA/NDA).
- Proficiency with Microsoft Word, PowerPoint, and Excel.
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