VP, Regulatory Affairs | REMOTEImplaion Recruiting • Durham, North Carolina, United States
VP, Regulatory Affairs | REMOTE
Implaion Recruiting • Durham, North Carolina, United States
30+ days ago
Job type
- Full-time
- Quick Apply
Job descriptionTake charge of planning, drafting, and submitting global regulatory filings including INDs, NDAs, CTAs, MAAs, and pediatric development plansowning everything from original submissions to post-approval documentation. Lead cross-functional teams spanning nonclinical, clinical, CMC, stats, and operations, pushing programs forward while meeting tight timelines and quality expectations. Drive strategic and hands-on regulatory operations throughout the product lifecyclefrom first-in-human to commercialization. Partner with clinical and safety teams to manage labeling, risk mitigation strategies, pharmacovigilance requirements, and lifecycle management. Interface directly with regulatory bodies (FDA, EMA, and others) and confidently lead agency meetings, teleconferences, and written communications. Evaluate and implement fast-track mechanisms, adaptive design approaches, and other accelerated regulatory pathways to compress development timelines. Ensure internal teams and external partners are aligned and equipped to meet regulatory milestones on time. Oversee external regulatory writers and consultants, balancing internal ownership with outsourced support. Maintain sharp awareness of global regulatory shiftsincluding FDA, EMA, and evolving EU regulationsand translate that into forward-looking action. PharmD, PhD, or MD strongly preferred. Minimum 10 years in Regulatory Affairs within biopharma, including substantial late-stage and global submission experience. Hands-on leadership in at least two successful NDA submissions for novel therapeutics (rare disease background a plus), with meaningful post-approval involvement. Proven track record preparing for and navigating regulatory inspectionscalm under pressure, thorough in execution. Must have worked in a nimble, small-company setting and be energized by wearing multiple hats in a high-accountability, low-bureaucracy culture. Strong command of international regulatory frameworks, including EU Clinical Trial Regulation and CTIS. Comfortable leading Advisory Committee strategies and commercial label expansion efforts. Fluent in GxP, FDA / ICH guidance, and global PV standards. Experience with small molecule programs, ideally in immunology or autoimmune indications. Skilled at toggling between high-level strategy and detail-driven executionyou dont shy away from writing submissions yourself. Clear communicator, quick thinker, strong collaborator, and decisive leader.
Vice President, Regulatory Affairs | REMOTE | Pre-IPO
Critical Elements
- Directly oversaw, or significantly contributed to, 2+ successful NDAs
- Global regulatory approvals
- Significant post-approval experience
- Inspection readiness - labeling
- Small company background
- Nimble - Adadptable - Entreprenurial
- Support within aggressive risk parameters
Overview
Were looking for a regulatory leader whos done this beforesomeone whos successfully led multiple NDA submissions, can guide a team through inspection readiness with confidence, and thrives in the dynamic pace of a small biotech. Reporting directly to an Executive Officer, youll play a central role in advancing our late-stage programs globally. This isnt a set the strategy and delegate positionits a roll-up-your-sleeves, be-in-the-details, steer-the-ship kind of role.
What Youll Do
What You Bring
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