Confidential
Vice President, Regulatory Affairs & Quality Assurance
Confidential, Lexington, Massachusetts, us, 02420
Vice President, Regulatory Affairs & Quality Assurance
About the Company
Innovative gene therapy company
Industry Pharmaceuticals
Type Public Company
Founded 2014
Employees 51-200
Categories
Manufacturing Pharmaceuticals Medicine Chemical Products Biotechnology
Specialties
gene therapy biotechnology adeno associated virus research parkinson's disease huntington's disease vector engineering sf9 alzheimer's disease als amyotrophic lateral sclerosis friedrich's ataxia sod-1 tauopathies neurology neuropharmacology and cns
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
Medical Care/Hospital Administration
About the Company
Innovative gene therapy company
Industry Pharmaceuticals
Type Public Company
Founded 2014
Employees 51-200
Categories
Manufacturing Pharmaceuticals Medicine Chemical Products Biotechnology
Specialties
gene therapy biotechnology adeno associated virus research parkinson's disease huntington's disease vector engineering sf9 alzheimer's disease als amyotrophic lateral sclerosis friedrich's ataxia sod-1 tauopathies neurology neuropharmacology and cns
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
Medical Care/Hospital Administration