Executive Director, Regulatory Affairs Strategy, Cell & Gene Therapy
Confidential
Executive Director, Regulatory Affairs Strategy, Cell & Gene Therapy
About the Company
Respected biopharmaceutical company
Industry
Pharmaceuticals
Type
Public Company
Founded
1999
Employees
10,001+
Categories
- Health and Wellness
- Medical
- Pharmaceuticals
- Biotechnology - See more at:
- Biotechnology and Pharmaceuticals
- Health Care Information Technology
- Pharmaceutical Manufacturing
- User Experience Design
- Ux Designer
- Manufacturing
- Academic Research
- Health Care
- Biotechnology
- International Trade
- Healthcare
- Clinical Care
- Health
- Corporate Citizenship
- Sustainability
- Medicine
- Chemical Products
- Biopharma
- Precision Medicine
Specialties
- pharmaceutical
- biopharmaceutical
- innovation
- research and development
- and global business
Business Classifications
- B2B
- Enterprise
About the Role
The Company is seeking a Senior Director for Regulatory Affairs Strategy in Cell and Gene Therapy. This pivotal role is focused on setting the global regulatory vision for innovative therapies, particularly those targeting cancer, immune-mediated, and rare diseases. The successful candidate will be responsible for leading high-impact programs, guiding them through the regulatory process with a clear and competitive strategy, and ensuring efficient routes to approval that align with the needs of patients, the market, and the business. The role demands a strategic leader who can anticipate risks, seize opportunities, and influence global health authorities. The Senior Director will also be accountable for global regulatory leadership, health authority strategy, and engagement, as well as for the planning and construction of the global dossier and core prescribing information. Applicants for this role at the company should have an advanced degree in a science-related field, with 7-10 years' of experience in regulatory affairs, particularly in the area of cell and gene therapy. A deep understanding of global regulatory science, drug/biologic development processes, and experience in therapeutic areas such as oncology, autoimmune, rare diseases, and neurology are essential. The role requires a proven track record in leading regulatory and cross-functional teams, excellent communication skills, and the ability to think strategically and critically. Experience in leading health authority interactions, as well as a successful history of global regulatory approvals, is also necessary. The ideal candidate will be a strong leader, capable of managing multiple projects, and will have a proactive, flexible approach to work.
Hiring Manager Title
Executive Director
Travel Percent
Less than 10%
Functions
- Strategy
Vacancy posted 17 hours ago
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Confidential
Gaithersburg, MD2 days ago
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