We are seeking a Director of Regulatory Affairs. In this role you will be responsible for developing and implementing global regulatory strategies for Apogee’s portfolio of projects. This role provides leadership in the strategic guidance and execution of regulatory concepts within cross-functional project teams and supports interactions with global health authorities and corporate partners with regulatory deliverables. In this newly created role you will proactively anticipate and mitigate regulatory risks, ensure compliance with global regulatory requirements, implement regulatory aspects of clinical trials, collaborate with CMC team to ensure regulatory CMC strategies are implemented, and lead the 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
• 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
• Support the preparation of, and participate in / lead (as appropriate), key health authority interactions
• Execute preparation of regulatory documentation including cross-functional authoring and/or reviewing and maintenance of initial applications, routine amendments, responses to information requests, meeting background materials/scientific advice to support interactions with (Health Authorities) HAs, INDs, CTAs, annual reports, IND safety reports/DSURs, and correspondence with HAs
• 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