Job Title: Vice President, Regulatory & Quality
Location: Thousand Oaks or San Francisco
Company Description: Latigo Biotherapeutics, Inc. is a private, early-stage biotechnology company focused on discovering and developing the next generation of non-opioid medicines for pain and pain-related syndromes. Our mission is the development of novel therapies that transform the lives of patients. The company is headquartered in Thousand Oaks, CA and has a highly successful management team as well as an experienced Board of Directors. At Latigo, we value science, patient-focus, and innovation.
Position Overview: The Vice President, Regulatory & Quality will be a key member of the executive team, responsible for leading the regulatory affairs and quality assurance functions. This role will ensure compliance with all applicable regulations and standards and will drive the regulatory strategy for the company's innovative non-opioid pain medicines. The VP will work closely with cross-functional teams to support the development, approval, and commercialization of the company's products.
Key Responsibilities:
Regulatory Affairs:
- Develop and implement regulatory strategies to ensure timely approval of clinical-stage products.
- Lead interactions with regulatory agencies (FDA, EMA, etc.) and manage all regulatory submissions, including INDs, NDAs, and MAAs.
- Monitor and interpret regulatory requirements and ensure compliance with all applicable regulations.
- Provide regulatory guidance to cross-functional teams, including clinical, preclinical, and manufacturing.
- Oversee the preparation and submission of regulatory documents and ensure accuracy and completeness.
Quality Assurance:
- Develop and maintain a robust Quality Management System (QMS) in compliance with GxP regulations.
- Ensure all clinical and manufacturing activities comply with applicable quality standards and regulations.
- Lead internal and external audits and inspections and manage responses to regulatory findings.
- Oversee the development and implementation of quality policies, procedures, and training programs.
- Collaborate with manufacturing and clinical teams to ensure product quality and safety.
Leadership and Management:
- Build and lead a high-performing regulatory and quality team.
- Provide strategic direction and mentorship to team members.
- Foster a culture of compliance, quality, and continuous improvement.
- Collaborate with executive leadership to align regulatory and quality strategies with business objectives.
Cross-Functional Collaboration:
- Work closely with R&D, clinical, and commercial teams to support product development and commercialization.
- Provide regulatory and quality input into clinical trial design, manufacturing processes, and marketing strategies.
- Ensure effective communication and collaboration across all departments.
Experience and Required Skills:
- Bachelor’s degree in a scientific discipline. Advanced degree preferred.
- Minimum of 15 years of experience in regulatory affairs and quality assurance in the biopharmaceutical industry.
- Proven track record of successful regulatory submissions and product approvals.
- In-depth knowledge of FDA, EMA, and other global regulatory requirements.
- Strong leadership and team management skills.
- Excellent communication and interpersonal skills.
- Ability to work effectively in a fast-paced, dynamic environment.
- Experience with pain management products or non-opioid therapies is highly desirable.
Salary: Ranges from $280,000 to $320,000
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