Senior Director, Regulatory Affairs

Summary

Join Apogee Therapeutics as their Senior Director, Regulatory Affairs and lead the development and implementation of global regulatory strategies for their portfolio of projects. Collaborate with cross-functional leaders and senior management to ensure compliance with global regulations. This role involves interacting with health authorities, preparing regulatory documents (INDs, CTAs, BLAs, MAAs), and mitigating regulatory risks. The ideal candidate possesses a BS/MS/PhD in a related field, extensive regulatory experience in the biopharmaceutical industry, and strong project management skills. Apogee offers a competitive compensation and benefits package, including a base salary, performance bonus, equity grants, health and welfare benefits, flexible PTO, and professional development opportunities.

Requirements

• BS/MS/PhD (or equivalent) in regulatory affairs or related scientific discipline
• A minimum of 10 years of regulatory experience working in drug development in the biopharmaceutical industry, or equivalent based on training and experience
• 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

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

Preferred Qualifications

• Regulatory Affairs Certification (RAC) credential
• Experience in inflammatory & immunological therapeutic areas
• Strong preference for candidates with biologics experience

Benefits

• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Flexible PTO
• Two, one-week company-wide shutdowns each year
• Commitment to growing you professionally and providing access to resources to further your development
• Apogee offers regular all team, in-person meetings to build relationships and problem solve