Senior Director, Regulatory Affairs

Role

Senior Director of Regulatory Affairs overseeing global regulatory strategies for biologics development, with a focus on late-stage filings.

Responsibilities

• lead IND, BLA, sBLA submissions
• develop regulatory scientific and tactical strategies
• liaise with FDA, EMA, MHRA
• oversee regulatory documentation including CTDs, briefing documents, labeling
• provide leadership within cross-functional development teams, including mentoring direct reports
• ensure compliance with global regulatory requirements
• contribute to procedures for late-stage development and commercialization
• manage health authority interactions and review clinical trial labeling and CMC submissions

Requirements

• advanced degree (MS, PharmD, PhD, MD) with 8-12 years' (MS) or 10-15 years' (BS) experience
• extensive knowledge of US and global regulatory environments
• proven experience in preparing IND/CTA, BLA/NDA submissions, including at least one NME BLA/NDA
• strong leadership, communication, and interpersonal skills
• experience in biologics, late-stage development, and health authority meetings

HighValue

• biologics
• late-stage development
• global regulatory submissions
• FDA interactions
• IND/BLA filings
• regulatory strategy development

WorkSetup

roles based in Gaithersburg, MD or Radnor, PA, with potential for global interaction and oversight.