Title: Regulatory/Compliance Scientist
A pharmaceutical company focused on developing and marketing high quality branded and generic prescription, Nutraceutical, and OTC pharmaceutical products is seeking a Regulatory/Compliance Scientist to join their growing team! This is an onsite position in Greater Chicago and the ideal candidate will have hands on technical experience in drug development to bring to the team.
Responsibilities:
- Perform review of current FDA applications (approved, under review and post-approval) for current regulations and draft guidance.
- Provide accurate assessment of all products and compliance status, develop an effective program to monitor and execute future submissions.
- Conduct supplier/CMO audits and provide an assessment for the compliance of GMP and the FDA regulations pertaining to our products.
- Develop a program to monitor and perform routine audits.
Qualifications:
- Bachelor's degree in chemistry, pharmacy, biochemistry or closely related field/major.
- 3-5 years experience in Regulatory Affairs within pharma
- 2+ years of experience with ANDA/510k submissions
- 1-3 years experience in quality/compliance within pharma/OTC field
- Hands-on supplier qualification/audit experience
- Hands-on technical experience in the drug development process
- Ability to read, interpret and develop plans for the regulatory compliance and written procedures.
