Senior Vice President, Regulatory Affairs

About the Company

Innovative biotechnology (BioTech) company specializing in genomic medicines

Industry
Biotechnology

Type
Privately Held

Founded
2021

Employees
51-200

Categories

• Academic Research
• Biotechnology
• Genomics
• Pharmaceuticals
• Health Care
• Therapeutics
• Laboratory Services

About the Role

The Company is seeking a VP/SVP, Regulatory Affairs, and Quality Assurance to lead the development and execution of global regulatory strategies for its innovative epigenetic editing medicines portfolio. This pivotal role involves shaping the regulatory pathway, ensuring compliance with global requirements, and driving the design and execution of global registration strategies. The successful candidate will be accountable for the development and implementation of effective CMC regulatory strategies, overseeing regulatory operations, and managing quality systems and compliance strategies. Collaboration with internal and external partners, acting as a liaison with regulatory agencies, and monitoring the regulatory landscape to proactively manage risks are also key responsibilities. The role requires a deep understanding of regulatory requirements for gene therapy products and the ability to lead a team of regulatory professionals in a fast-paced, innovative environment.Candidates for this role at The Company should possess an advanced degree in life sciences or a related field, with a preference for a PhD, MD, or equivalent. A minimum of 10 years of experience in regulatory affairs within the biopharmaceutical industry, specifically in the area of genomic medicine, is required. The ideal candidate will have a proven track record of successful regulatory submissions and interactions with health authorities, including experience with pre-IPO companies and innovative therapies. Deep knowledge of global regulatory requirements, guidelines, and best practices, as well as experience with the Code of Federal Regulations, FDA, EMA, and ICH guidelines, is essential. The role demands strong leadership, communication, and collaboration skills, as well as the ability to manage a team and budget within financial goals. A passion for driving cutting-edge science and the ability to thrive in a fast-paced, evolving biotech startup environment are also key attributes.

Hiring Manager Title
Chief Executive Officer

Travel Percent
Less than 10%

Functions

• Medical Care/Hospital Administration
• Strategy