Sr. Manager/Associate Director Regulatory Affairs
In this role, you will have the opportunity to work independently and collaboratively in an exciting young but growing company.
The Associate Director/Sr. Manager in Regulatory Affairs is responsible for developing and managing regulatory strategies to remain compliant with U.S. FDA and global regulatory bodies. This position is responsible for planning, drafting, managing global regulatory submissions with personnel within and external to the company. This individual will work closely with clinical development, non-clinical, manufacturing, technical operations, and external stakeholders to ensure regulatory success.
Job Duties and Responsibilities:
Responsibilities may include, but are not limited to:
- Manage the preparation and submission of briefing packages and coordinate the sections of INDs, IMPDs, CTAs, and NDAs/BLAs.
- Responsible for preparing and coordinating company responses to queries from health authorities.
- Extensive knowledge of regulatory requirements, including ICH and regional requirements and an understanding of current global and regional trends in regulatory affairs.
- Provide expert guidance roll-out and implementation of new and ongoing regulatory activities to support company goals.
- Responsible for timely compilation of all necessary documents to support regulatory submissions.
- Ensure cross-functional alignment on regulatory strategies.
- Bachelor’s degree in science or health field required; advance degree is a plus
- 5+ years experience in regulatory affairs, clinical drug development, manufacturing, or clinical related function in the pharmaceutical or biopharmaceutical industry
- Broad and strong understanding of international regulations and guidelines, as well as industry practices in clinical development of drug or biologic drugs.
- Experience with CTD/eCTD and life cycle management. In-depth knowledge of ICH requirements and US/EU regional requirements.
- Excellent attention to detail and accuracy.
- Excellent verbal, written, negotiation, and interpersonal communication skills are required.