Vice President, Regulatory Affairs & Quality (GxP)
Confidential
Vice President, Regulatory Affairs & Quality (GxP)
About the Company
Clinical-stage biopharmaceutical company
Industry
Biotechnology
Type
Public Company
Founded
2016
Employees
11-50
Categories
- Pharmaceuticals
- Biotechnology
- Health Care
- Health Diagnostics
- Pharmaceutical
- Recruiting
- Therapeutics
- Academic Research
- Laboratory Services
- Medicine
- Manufacturing
- Chemical Products
Specialties
- fibrosis
- integrins
- muscle biology
- oncology
- duchenne muscular dystrophy
- idiopathic pulmonary fibrosis
- primary sclerosing cholangitis
- muscular dystrophy
- metabolic dysfunction-associated steatohepatitis
- and mash
- mash
- and drug development
About the Role
The Company is in search of a Vice President for Regulatory Affairs and Quality (GxP) to lead and integrate these critical functions for its portfolio of programs, with a focus on oncology. The successful candidate will be responsible for developing and executing global regulatory strategies across the product development lifecycle, from IND/CTA to planning for pivotal development. This hands-on leadership role involves day-to-day management of regulatory and quality teams, serving as the primary interface with health authorities, and ensuring compliance with all relevant regulations. The VP will also be involved in strategic decision-making regarding regulatory pathways and designations, and will be accountable for the company's portfolio pipeline's development in full compliance with applicable regulations. Applicants must have a Bachelor's degree in a scientific field, with an advanced degree preferred, and at least 15 years of experience in regulatory affairs and/or quality within the biotech or pharmaceutical industry, including direct oncology drug development experience. A minimum of 8 years in a senior leadership role is required, along with a proven track record in preparing and submitting regulatory filings, particularly for early-phase oncology assets. The role demands a deep understanding of GxP requirements and experience with oncology-specific regulatory designations. The ideal candidate will be a strategic advisor to the executive team, possess excellent communication skills, and be adept at managing relationships with external partners. Experience in scaling regulatory and quality functions and a background in small molecule or targeted therapy development programs are preferred.
Hiring Manager Title
Chief Operating Officer
Functions
- Operations
Vacancy posted 2 days ago
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