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Director, Regulatory Affairs - New Opportunity!!!!
Morris Executive Search
Boston , MA 02109
Posted 3 weeks ago
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Director, Regulatory Affairs
The Director, Regulatory Affairs will serve as the global regulatory lead for assigned programs. This role requires expert interpretation of requirements relating to the development and licensing of pharmaceuticals and communication to cross-functional teams to create innovative regulatory strategies.Responsibilities:
- Part of the Executive Team, responsible for managing and executing Regulatory submissions as well as developing and implementing regulatory strategies;
- Ensure regulatory compliance with pre- and post-approval filings and reporting requirements;
- Develop response strategies and submissions to regulators as well as contribute to the development and implementation of clinical, pre-clinical, as well as regulatory strategies for projects in all stages of development;
- Provide regulatory leadership and guidance to project teams and junior staff members;
- Manage and/or delegate the completion of documents and other assigned tasks within established timelines;
- Integrate global regulatory understanding and responsibilities in developing strategies and the development of regulatory submission documents;
- Prepare and deliver effective presentations for external and internal audiences.
- M.S. degree in life sciences required with 8+ years regulatory experience in the biotech/pharmaceutical industry or;
- /PharmD with at least 5+ years experience in the biotech or pharmaceutical industry;
- At least 5+ years regulatory experience with drug development and approval processes in IND/CTAs/Marketing Applications
Please email your interest to firstname.lastname@example.org.