This global pharmaceutical company is seeking a Senior Director, Regulatory Team Leader to oversee its Rare Disease portfolio. In this role you will provide strategic input into US and global regulatory strategies, while leading a team of direct reports. You will also serve as the primary contact with the FDA and other health authorities. This position can be located at either the company’s New Jersey headquarters or their campus in Massachusetts. This is an exciting time to manage this growing team, get new products approved, and help patients around the world.
- Develop and lead global regulatory strategies for a portfolio of Rare Disease and Rare Blood Disorder programs.
- Lead and coach a team of direct reports, and foster a productive team culture.
- Organize and lead the preparation of clear and effective regulatory submissions.
- Engage with and foster successful relationships with regulatory agency personnel and negotiate with regulatory authorities regarding company’s filings.
- As a Regulatory expert, you will provide input on clinical trials strategies and filing activities and ensure that reporting systems are maintained and compliant with regulations.
- Spearhead communication of the regulatory strategy, risks, mitigations, and overall plans to the internal management teams as well as the executive management team.
- Maintain awareness of the changing regulatory landscape and advises team on changes that could impact future development.
- Oversee life cycle management plans for successful outcomes for the organization.
- Lead the preparation of effective presentations for external and internal audiences.
- Identify department inefficiencies or gaps and lead the development and implementation of new process improvements.
- Bachelor’s degree in a scientific discipline required. Advanced degree preferred.
- 12+ years’ experience in regulatory affairs for drug development.
- Direct management experience with leadership of three or more direct reports required.
- Direct experience in managing successful partnerships with FDA and other health authorities.
- A successful track record of developing and executing regulatory strategies for US INDs, BLA, and/or NDA approved products.
- Experience with rare or ultra-rare diseases experience required. Therapeutic area expertise in regulated products for rare blood disorders (Hemophilia, aTTP, PCV, Myelofibrosis, Cold Agglutinin Disease, Sickle Cell, or Beta Thalassemia) desired.
- Direct experience working on products in early development phases specifically relating to clinical and pre-clinical project under GCP and GLP settings.
- Ability to digest and work with complex medical and scientific subject matter and related new regulations.
- Ablility to organize written reports and present with excellent oral communication and writing skills.
- Ability to travel for required meetings with FDA and other aligned duties when needed.