Senior Director, Regulatory Affairs

The Senior Director, Regulatory Affairs is responsible for developing and implementing global regulatory strategies for Apogee’s portfolio of projects. This role works closely with cross functional leaders in all regulatory interactions and activities for the development of Apogee’s therapeutic candidates. The position includes responsibility for the development and refinement of regulatory strategy working in collaboration with senior management, to ensure compliance with applicable global regulations, standards, and clinical practice guidelines.  The position supports interactions with global health authorities and corporate partners with regulatory deliverables. The incumbent proactively anticipates and mitigates regulatory risks, ensures compliance with global regulatory requirements, implements regulatory aspects of clinical trials, collaborates with CMC team to ensure regulatory CMC strategies are implemented, and leads development and submission of regulatory documents.

Key Responsibilities 

• Serve as global regulatory lead on project teams and workstreams
• Ensure global regulatory strategies are aligned with senior management and corporate goals are met
• Perform critical review of submission documents to ensure compliance with regulatory requirements
• Understand trends and requirements associated with global government regulatory activities and the impact of changes on the company’s product portfolio to assess the cost benefit, risk management implications for the company
• Develop and implement competitive and effective global regulatory strategies for Apogee programs including cross-functional considerations that enable risk characterization and mitigation strategy development
• Serve as primary Health Authority contact for assigned projects and foster positive and effective working relationships between project team members and Health Authority reviewers
• Lead preparation of team and documents, and participate in key health authority interactions
• Leads continuous improvement efforts on existing department processes and strategies, providing recommendations in areas of expertise
• Provide leadership and direction in the development of nonclinical and clinical regulatory documents including INDs, CTAs, BLAs, and MAAs; this may involve writing some relevant sections of documents
• Follow company policies and procedures for regulatory record keeping; may develop and implement policies and procedures in collaboration with Quality Assurance; ensure direct reports follow requirements

Ideal Candidate 

• BS/MS/PhD (or equivalent) in regulatory affairs or related scientific discipline
• Regulatory Affairs Certification (RAC) credential preferred
• A minimum of 10 years of regulatory experience working in drug development in the biopharmaceutical industry, or equivalent based on training and experience
• Strong preference for candidates with biologics experience
• Experience in inflammatory & immunological therapeutic areas preferred
• Strong project management skills with high sense of urgency and the ability to collaborate and influence effectively cross-functionally
• Significant experience interacting with major health authorities in the US, EU, and elsewhere
• Knowledgeable of pharmaceutical regulations and an ability to identify and interpret legislation, guidelines, and relevant information published by global health authorities
• Strong analytical, written and verbal communication skills and ability to present material catered to a variety of target audiences with a broad range of regulatory competency
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Detail-oriented with ability and desire to work in a fast-paced, nimble, hands-on, team-oriented, biotech environment
• Position requires up to 15% travel

The anticipated salary range for candidates for this role will be $250,000-$285,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.