I am currently partnering with a growing, innovation-driven pharmaceutical company to appoint a Director/Senior Director of Regulatory Affairs . This is a fully remote, U.S.-based opportunity offering a key leadership role within a dynamic and expanding organisation. About the Role The Director of Regulatory Affairs will lead regulatory strategy and execution across development programs, working closely with senior leadership and cross-functional teams. This individual will play a critical role in guiding products through the regulatory pathway toward approval and commercialization. Key Responsibilities Develop and implement global regulatory strategies aligned with business objectives and development timelines Lead the preparation, review, and submission of INDs, NDAs, BLAs, MAAs, and other regulatory filings Support primary liaison with the FDA and other health authorities, including leading meetings (pre-IND, end-of-Phase II, pre-NDA) Provide strategic regulatory input into clinical development plans, study designs, and endpoints Interpret regulatory guidelines and communicate risks, opportunities, and mitigation strategies to senior leadership Ensure compliance with all applicable regulatory requirements, including FDA, ICH, and GxP standards Oversee regulatory labelling strategy, including negotiation with health authorities Support due diligence activities, partnerships, and licensing opportunities from a regulatory perspective Collaborate cross-functionally with clinical, quality, CMC, and commercial teams to align regulatory strategy Manage regulatory timelines and deliverables to ensure alignment with overall program milestones Build, lead, and mentor the regulatory affairs function, including external consultants and vendors where applicable Stay current with evolving regulatory landscapes and proactively assess impact on development programs Candidate Profile Bachelor’s degree required; advanced degree (PhD, PharmD, or MS) preferred 10+ years of regulatory affairs experience within pharma or biotech Proven track record of successful FDA submissions and approvals Strong knowledge of U.S. regulatory frameworks; global experience advantageous Demonstrated leadership and ability to operate in a fast-paced environment Prior experience within a small or mid-sized company is highly desirable Willing to travel up to 30% domestically Opportunity Highlights Fully remote role (U.S.-based) High-impact position within a growing company Competitive compensation package including bonus and equity Collaborative, forward-thinking leadership team #J-18808-Ljbffr Medella Life
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