Associate Director / Director, Regulatory AffairsAbout the RoleWe 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.
Key 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 documentation, ensuring adherence to FDA and other global health authority specifications and timelines, including submissions, correspondence, and approvals, and ensuring accurate and organized records.
- Partner with Technical Operations to facilitate CMC gap analyses, regulatory impact assessments, and submissions.
- Manage third-party vendor and partner performance and workload to support regulatory operations and regulatory publishing.
- Provide project management support for regulatory and clinical projects, including defining project objectives, developing project plans, allocating resources, and monitoring progress to ensure timely completion.
- Serve as a point of contact and maintain effective relationships with regulatory agencies such as the FDA and EMA, ensuring open and constructive communication.
- Develop and implement standard operating procedures (SOPs), best practices, and quality control measures to ensure compliance with regulatory standards.
- Utilize project management tools and methodologies to effectively plan, track, and report on regulatory project status, milestones, and risks.
- Contribute to and help develop regulatory strategy plans that integrate regulatory interactions and milestones with clinical timelines.
- Stay current on evolving regulatory requirements, guidelines, and industry trends to proactively identify potential risks, opportunities, and organizational impact.
- Support management of regulatory budgets, resources, and timelines to optimize operational efficiency and meet business objectives.
Qualifications and Skills- 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.
- Experience with global regulatory requirements and guidelines (including FDA, EMA, and ICH) across preclinical and clinical stages; working knowledge of drug laws, regulations, guidelines, and product lifecycle management.
- 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.
- Excellent written and verbal communication skills, with the ability to translate complex regulatory concepts for diverse audiences.
- Detail-oriented, with excellent organizational and project management skills, capable of managing multiple projects and priorities simultaneously in a fast-paced environment.
