Our client, a global life sciences company, is seeking an experienced FDA lawyer for an in house role in New Jersey. This is a remote position with periodic visits to our client’s offices in New Jersey.
Responsibilities:
- This position will have a global scope and focused on providing legal counsel on a broad range of matters related to Global Quality, Regulatory Affairs, and Operations across the company’ platforms on issues including compliance with GMP, FDA, EMA, GxP, and other global regulations and guidelines.
- Negotiate and draft complex quality agreements and other documents (Form 483) related to manufacturing and testing and assess impact on commercial agreements.
- Advise leadership on product complaints, potential quality issues, investigations, root cause analyses, and risk mitigation.
- Assist with internal and external audits and inspections
- Identify areas of risk in quality/regulatory areas and lead the development and implementation of mitigation strategies to ensure quality and regulatory compliance.
Key Requirements
- JD Degree required
- In good standing of a State Bar in the U.S. and eligible to practice in New Jersey as in-house counsel
- 10+ years of professional legal experience, focused on quality and regulatory experience in the life sciences
Compensation
- Base salary of at least $190K, bonus, and a comprehensive benefits package.
- The final salary will be based on several factors, including, but not limited to, a candidate’s qualifications, training, skills, competencies, and experience.
