Senior Executive - Regulatory Affairs (Finished Oncology Products)
Smart Moves Consultants
5 - 10 years
Mumbai
Posted: 30/12/2025
Getting a referral is 5x more effective than applying directly
Job Description
About the Company
Candidate should be from RA, and actively involved in regulatory affairs function on finished dosage form.
About the Role
Sound and deep knowledge in to current Regulatory / GMP requirements (US FDA, EU GMP, PIC/s).
Responsibilities
- Compile and review product dossiers.
- Conduct gap analysis.
- Handle customer and MOH queries.
- Manage product life cycle.
- Handles on Development report, specification, COA, stability protocol and Process validation protocol.
- Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability).
- Re-registration (Renewal) procedures.
- Administrative documents requirements (COPP, Mfg. License and Import License).
- Monitor validity of the Registrations of the FG and Plant GMPs etc.
Required Skills
Sound and deep knowledge in to current Regulatory / GMP requirements (US FDA, EU GMP, PIC/s).
Services you might be interested in
Improve Your Resume Today
Boost your chances with professional resume services!
Get expert-reviewed, ATS-optimized resumes tailored for your experience level. Start your journey now.
