Backed by GV.
About the role
We are seeking a highly skilled and experienced Associate Director / Director of Regulatory Affairs to join our growing clinical team. This hands-on position will be responsible for overseeing and managing global regulatory activities to ensure compliance with applicable laws, regulations, and guidelines. In this role, you will contribute to and help implement regulatory strategy, prepare and manage regulatory submissions, and help guide the company through complex regulatory landscapes.
What they're looking for
- Bachelor's degree in life sciences, pharmacy, or a related field, advanced degree (MS, PharmD, PhD, or equivalent) preferred
- Minimum of 8+ years of regulatory affairs experience within the biopharmaceutical industry, oncology experience strongly preferred
- Particular interest in candidates with EU and ex-US regulatory experience (e.g. CTAs, CTR/CTIS, MAAs, PIPs, SA)
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal teams, external partners, and regulatory authorities
- Experience supporting or managing regulatory inspections, audits, and interactions with regulatory agencies, including direct agency contact
- Experience contributing to or executing regulatory strategies for complex products or therapies, including regulatory interactions, submissions, filings, and approvals
More about this role
We are seeking a highly skilled and experienced Associate Director / Director of Regulatory Affairs to join our growing clinical team. This hands-on position will be responsible for overseeing and managing global regulatory activities to ensure compliance with applicable laws, regulations, and guidelines. In this role, you will contribute to and help implement regulatory strategy, prepare and manage regulatory submissions, and help guide the company through complex regulatory landscapes. The successful candidate will have experience in, and enthusiasm for, working in a small, dynamic environment with broad responsibilities.
- Collaborate cross-functionally with internal teams, including Clinical, Clinical Operations, Quality Assurance, Pharmacovigilance, Clinical Pharmacology, Technical Operations, and Non-Clinical/Toxicology, to prepare, review, and submit high-quality regulatory submissions, including INDs, NDAs, BLAs, briefing books, orphan drug designation requests, pediatric plans, and other relevant applications, ensuring compliance with regulatory requirements and timelines.
- Contribute to (Associate Director) or hold final accountability for (Director) regulatory...
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