Key Responsibilities
- Prepare, review, and submit Drug Master Files (DMFs), dossiers, and regulatory documentation to authorities (e.g., USFDA, EMA, CDSCO).
- Monitor and interpret regulatory requirements across international markets.
- Support product registrations and maintain updated regulatory databases.
- Liaise with cross‑functional teams (R&D, QA/QC, production) to ensure compliance during development and commercial manufacturing.
- Handle regulatory queries from authorities and clients.
- Track changes in ICH, GMP, and pharmacopoeial standards and implement necessary updates.
Skills & Competencies
- Strong knowledge of global regulatory frameworks (USFDA, EMA, WHO, CDSCO).
- Expertise in technical documentation and submission formats (CTD/eCTD).
- Attention to detail, analytical thinking, and ability to interpret complex guidelines.
- Effective communication and coordination skills for cross‑functional collaboration.
Qualifications
- Bachelor’s/Master’s degree in Pharmacy, Chemistry, or Life Sciences.
- Prior experience in regulatory affairs within API/pharma manufacturing preferred.
Pay: ₹20,000.00 - ₹50,000.00 per month
Benefits:
- Health insurance
- Leave encashment
- Paid sick time
- Paid time off
- Provident Fund
Work Location: In person
