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Head of Regulatory Affairs, Sr. / Exec. Director

New York, NY 10010

Posted: 03/23/2023 Employment Type: Direct Hire/Perm Job Category: Regulatory Sciences and Medical Writing Job Number: 553283 Is job remote?: No Country: United States

Job Description

Position Summary: Provide leadership of all regulatory activities that support product development and commercialization of drug products. 

Key Responsibilities:
  • Provide regulatory leadership and support to across multiple molecules and multiple indications
  • Responsible for the US and ex-US regulatory activities associated with the project teams.
  • Develop regulatory scientific, and tactical strategic plans, and target labelling to support development of products.
  • Lead development and participate in writing of regulatory submission documents, including Briefing documents, IND/CTA supporting documents, labelling, and NDA/BLA/MAA documentation for eCTD compliant submissions.
  • Contribute to the development of procedures (SOPs) and working practices commensurate with industry and regulatory requirements.
  • Overseeing regulatory review of clinical trial labelling and CMC submissions for regulatory compliance, in conjunction with Regulatory CMC colleagues.
  • Demonstrate a high level of professionalism, efficiency, and leadership within the team whilst demonstrating critical thinking, effective problem solving and a strong knowledge of regulatory strategies and compliance with all regulations and applicable guidance.
  • Responsible for reviewing and ensuring the quality of detailed scientific and technical information are presented clearly and supporting conclusions are adequately evidenced by the data.
Experience & Knowledge:
Education: BS, MS, PhD in scientific or related field
  • 10+ years of industry regulatory affairs experience in drug development, submissions and project lifer cycle activities. 
  • Leadership and collaboration skills within a dynamic project team(s).
  • Ability to recognize emerging trends in the regulatory landscape and assess impact on development and submission strategies.
  • Strong understanding of global and US regulatory requirements to be able to form functional regulatory strategies.
  •  Strong communication skills with colleagues, stakeholders, and agency representatives
  • Ability to foster department growth and provide mentorship to colleagues and peers.
  • Experience in supporting global clinical studies.
  • Experience in managing, preparing, submitting INDs/CTAs, BLAs/NDAs, and MAAs.
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