Associate Director Regulatory Affairs

Associate Director, Regulatory Affairs

Responsibilities:
- Develop and implement regulatory strategies to support timely submission and approval of pre-clinical submissions, clinical trial applications, marketing applications, and lifecycle maintenance (e.g., DSUR, annual reports).
- Translate regulatory requirements into practical, workable plans.
- Provide regulatory support and guidance to product development, project teams, and ex-US development partners.
- Contribute input to key IND/CTA documents (e.g., clinical protocols, study reports, investigational brochures).
- Plan, prepare, and review submissions to U.S. and ex-U.S. regulators throughout the program lifecycle; represent Regulatory Affairs for ex-US submissions managed by assigned CROs.
- Ensure activities align with U.S., ex-U.S., ICH, and other applicable requirements.
- Ensure regulatory documents are accurate, complete, verifiable, and compliant.
- Interpret and advise on regulations, directives, and guidance.
- Assist in drafting consistent responses to regulatory requests for information.

Education & Experience:
- Bachelor’s degree in a scientific discipline and at least 8 years of related experience (or equivalent combination).

Skills/Qualifications:
- Strong regulatory knowledge (U.S./ex-U.S.; emerging markets preferred).
- Experience preparing and submitting regulatory documents.
- Experience with investigational drugs, including BLA/NDA submissions and lifecycle management.
- Ability to work in a fast-paced environment with minimal supervision; adapt under pressure.
- Ability to prioritize multiple responsibilities and follow through timely.
- Strong collaboration and effective verbal/written communication skills.
- Proficiency with business productivity software (Excel, Word, PowerPoint, etc.).
- Travel may be required.