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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.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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