Director of Regulatory Affairs
Medella Life, New York, NY, United States
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
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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