Job Title: Senior Director Regulatory Affairs
Job Number: 35623
Location: San Diego,CA
Job Description $250-320K
Onsite/Hybrid in San Diego
Regulatory Operations
The Senior Director Regulatory Affairs is responsible for developing and executing a consolidated regulatory strategy to ensure market access for assigned products in specific indications. This role requires leadership in establishing and maintaining strong relationships with regulatory agencies, especially the FDA, and managing a team responsible for preparing regulatory submissions. As a core project team member, the Senior Director collaborates with cross-functional teams and regulatory bodies to secure and maintain product approvals.
Responsibilities Essential Duties and Responsibilities: Develop and implement regulatory strategy for assigned projects. Lead regulatory affairs efforts for project teams and supervise regulatory staff. Serve as the primary liaison with the FDA and other regulatory agencies. Communicate regulatory strategies to management, cross-functional teams, and partners. Lead preparation of regulatory submissions, including INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications. Collaborate with functional groups to define submission contributions. Prepare the company team for meetings with health authorities. Coordinate with CROs for Health Authority submissions. Represent Regulatory Affairs in cross-functional teams. Stay informed on global regulatory trends, competitive landscapes, and industry practices. Contribute to the development and maintenance of regulatory processes and procedures. Required Skills Qualifications: Education: Bachelor's degree in a scientific discipline; advanced degree preferred. Experience: 15+ years in the pharmaceutical industry, including 10+ years in Regulatory Affairs. Experience in pulmonary and cardiovascular diseases is a plus. Expertise: Extensive experience in drug development, including product approval/launch and preparing FDA submissions (NDAs/BLAs). Familiar with global submission processes, eCTD content, and regulatory requirements. Skills: Strong organizational, communication, and time management skills. Ability to lead teams, innovate, and solve problems independently. Experience with drug/device combination products and building partnerships across functions to meet business goals. Travel: Domestic and occasional international travel (up to 20%).
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