Head of Regulatory Affairs, Sr. / Exec. Director
345 Park Ave South New York, NY 10010 US
Position Summary: Provide leadership of all regulatory activities that support product development and commercialization of drug products.
- 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.
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.
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.