What are the responsibilities and job description for the Senior Director Regulatory Affairs position at Vivid Resourcing?
Job Title: Senior Director, Global Regulatory Affairs – Early & Mid‑Stage Biologics
Location: Boston, MA or Hybrid/Remote
Industry: Biotechnology / Biopharma
Type: Full‑time
About the Opportunity
We’re partnering with a dynamic biotech company specialising in next‑generation biologic therapies (including novel gene‑ and cell‑based platforms). As the pipeline moves into early and mid‑stage clinical development, the organisation seeks a seasoned regulatory leader to shape and execute global regulatory strategy for their biologic portfolio.
Role Overview
As the Senior Director of Global Regulatory Affairs, you will lead regulatory planning and execution for early (IND/CTA) and mid‑stage (Poc/Phase II) biologic programs. You will act as the primary regulatory interface for global health authorities (FDA, EMA, other ICH‐regions), work in close partnership with clinical, CMC/manufacturing, nonclinical, and commercial teams, and provide regulatory leadership in partnerships, due‑diligence, and lifecycle planning.
What You’ll Do
- Develop and implement global regulatory strategies for novel biologic modalities (e.g., monoclonals, cell therapies, gene therapies) from preclinical through proof‑of‐concept and into Phase II/III.
- Manage the preparation and submission of INDs/CTAs, amendments, briefing packages, and other regulatory filings in multiple geographies.
- Lead regulatory interactions with global authorities (FDA, EMA, MHRA, PMDA, etc.), including scientific advice meetings, advisory committee preparation, and agency negotiations.
- Collaborate cross‑functionally with clinical development, nonclinical, CMC/manufacturing, quality, and commercial teams to align regulatory strategy with development and business objectives.
- Identify and assess regulatory risks and develop mitigation plans across programs.
- Oversee and manage regulatory consultants, vendors and external agencies as needed to support filings.
- Provide regulatory input into business development, due diligence, partnerships/licensing and portfolio decisions.
What You Bring
- Advanced degree in life sciences, regulatory affairs or related fields (e.g., PharmD, PhD, MS) preferred.
- 10 years of progressive regulatory affairs experience in biotechnology or pharma, with biologics experience strongly preferred.
- Demonstrated track record of leading global regulatory submissions and regulatory authority interactions (INDs, CTAs, MAAs/BLAs) and successfully navigating regulatory strategy for biologics.
- Strong working knowledge of biologics development pathways, ICH guidelines, and regulatory frameworks across US, EU and other major markets.
- Excellent leadership, communication, influencing and project‑management skills in a fast‑paced, cross‑functional environment.
- Prior experience in partnership/licensing discussions and regulatory due diligence is a plus.
Why This Role?
This is a high‑impact opportunity to join a cutting‑edge biotech organisation that’s driving innovation in therapeutic biologics. You’ll be in a visible leadership role, reporting to senior development leadership, and have the chance to shape regulatory strategy and influence key development decisions across high‑value programs.
