• , US

Company:  Confidential

Job Title: Senior Director/Executive Director, Regulatory Affairs

Job Number: 69021

Location: , US

Job Description

The Senior Director/Executive Director of Regulatory Affairs is responsible for developing and implementing global regulatory strategies for the company’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. 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. The position reports to the Sr. Vice President of Regulatory Affairs and Toxicology.


* 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 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

Required Skills

* BS/MS/PhD (or equivalent) in regulatory affairs or related scientific discipline * Regulatory Affairs Certification (RAC) credential preferred * A minimum of 7 years of regulatory experience working in drug development in the biopharmaceutical industry, or equivalent based on training and 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 * Strong/Emerging leader with a growth mindset, willing to learn from others, and dedicated to promoting a psychologically safe environment * Detail-oriented with ability and desire to work in a fast-paced, nimble, hands-on, team-oriented, biotech environment * Must be currently authorized to work in the United States without the need for visa sponsorship now or in the future * Ability and willingness to travel up to 25%

Application Deadline: 2023-12-25


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