Senior RA Manager- Contract - Princeton, NJ
Proclinical is seeking an experienced individual for the role of Senior Regulatory Affairs Manager - Consultant.
Primary Responsibilities:
This role will play a key role in advancing innovative healthcare solutions. In this pivotal position, the successful candidate will collaborate with cross-functional teams and regulatory authorities, ensuring compliance and excellence across all initiatives.
Skills & Requirements:
- Bachelor's degree in life sciences, pharmacy, or a related field; an advanced degree is preferred.
- Minimum of years in regulatory affairs within the pharmaceutical or biotech industries.
- Strong knowledge of FDA regulations and ICH guidelines.
- Excellent communication and team collaboration abilities.
- Proactive problem-solver who thrives in cross-functional environments and has a passion for improving healthcare outcomes.
The Senior RA Manager's responsibilities will be:
- Partner with the Senior Director to develop and execute regional regulatory strategies.
- Lead the preparation and submission of regulatory documents, ensuring alignment with regional and global requirements.
- Work closely with product development, manufacturing, and commercialization teams to integrate regulatory considerations into all processes.
- Build and maintain relationships with regional regulatory authorities, fostering clear communication and collaboration.
- Stay ahead of regulatory developments, providing insights and guidance to support organizational goals.
- Manage post-marketing activities, regulatory risks, and inspection readiness to ensure ongoing success.
If you are having difficulty in applying or if you have any questions, reach out to Nicholas Walker at ...@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.