Regulatory Affairs Professional/Sr. Regulatory Affairs Professional
On-site · Grand Rapids, Michigan, United States
Grand Rapids, Michigan, United StatesOn-siteFull TimeSenior LevelBachelors DegreeUnknown
Type
Full Time
Level
Senior Level
Education
Bachelors Degree
Company size
Unknown
Job Summary
Oversee regulatory affairs for GRAM CDMO, managing regulatory submissions (INDs, ANDAs, NDAs, DMFs), LOAs, FDA correspondence, and registrations; maintain FDA establishment registrations, product listings (NDC, SPL), develop SOPs, support audits, and collaborate with internal teams and clients on regulatory strategy for sterile parenteral products.
Required Qualifications
- Bachelor’s degree in Life Sciences or related field
- 10+ years of experience in the pharmaceutical industry and 6 years of hands-on experience in Regulatory Affairs with increasing responsibilities
- Working knowledge of regulatory requirements (FDA/ICH/EUGMP; GDUFA) and familiarity with regulatory submissions for INDs, ANDAs, NDAs, DMFs, CRL/DRL/IR ANDA, EU variation review responses, post-approval supplements and pre-submission meeting packages
- Knowledge of regulatory science and submission data requirements across all phases of product development for sterile parenteral products
- Knowledge of cGMP, ICH, and USP regulations or guidelines
- Excellent technical writing skills
- Experience preparing FDA correspondence
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.