Vice President, Regulatory Affairs & Quality Assurance
About the Company
Innovative gene therapy company
Industry
Pharmaceuticals
Type
Public Company
Founded
2014
Employees
51-200
Categories
Specialties
About the Role
The Company is seeking a Vice President for Regulatory Affairs and Quality Assurance to provide strategic leadership in all regulatory and quality activities across preclinical, clinical, and manufacturing stages. The successful candidate will be responsible for devising and implementing regulatory strategies, ensuring compliance with GxP regulatory requirements, and fostering strong relationships with FDA and international regulatory authorities. This role requires the ability to proactively identify and mitigate regulatory and quality risks, as well as to provide innovative solutions in complex regulatory landscapes. The VP will also be tasked with leading a high-performing team, overseeing global regulatory submissions, and maintaining quality systems to support product approval. Candidates for this position should have a BS degree in life sciences or a related area, with an advanced degree preferred, and a minimum of 10 years' experience in regulatory affairs strategy within the pharmaceutical industry. Specialized knowledge in drug development, product commercialization, and experience in neurology and gene therapy areas are also preferred. The role demands an enterprise leader with a proven track record in functional leadership, experience in writing and submitting regulatory INDs, and a strong background in global filing. The ideal candidate will have excellent communication, negotiation, and problem-solving skills, and the ability to influence and build cross-functional relationships.
Hiring Manager Title
Chief Medical Officer
Travel Percent
Less than 10%
Functions
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