Senior Vice President of Regulatory Sciences
Confidential
Senior Vice President of Regulatory Sciences
About the Company
Innovative biotechnology (BioTech) company specializing in mRNA therapeutics
Industry
Pharmaceuticals
Type
Privately Held
Founded
2017
Employees
51-200
Categories
- Biotechnology
- Manufacturing
- Pharmaceuticals
- Medicine
- Chemical Products
- Academic Research
- Laboratory Services
Specialties
- biotechnology
- synthetic biology
- rna therapeutics
- and immunotherapy
About the Role
The Company is seeking a Senior Vice President of Regulatory Sciences to play a pivotal role in the development and implementation of regulatory strategies for its innovative mRNA therapeutic programs. The successful candidate will be responsible for building and leading the regulatory sciences function, with a focus on global strategy, CMC, operations, and vendor management. This role demands a leader with a proven track record in regulatory strategy, particularly in the areas of INDs, BLAs, and global submissions, and a deep understanding of oncology. Experience in gene/cell therapies and rare diseases is highly valued. The SVP will be the primary point of contact for regulatory interactions, shaping the company's engagement with health authorities, and driving the regulatory strategy to align with the scientific core of the technology. Applicants for the Senior Vice President of Regulatory Sciences position at the company should have a Bachelor's degree in a scientific discipline, with advanced degrees strongly preferred, and at least 20 years of experience in regulatory strategy within the biotech or pharma industry. The role requires a hands-on approach, a strong understanding of global regulatory frameworks, and the ability to apply them creatively to platform-based assets. The ideal candidate will have a startup mindset, be comfortable with ambiguity, and demonstrate outstanding communication and leadership skills. Responsibilities also include fostering a culture of collaboration, mentoring teams, and being a trusted thought partner to senior leadership in portfolio prioritization and long-range development planning.
Hiring Manager Title
President, Co-Founder & Head of R&D
Functions
- Operations
- Strategy
Vacancy posted 2 days ago
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