Pelltech Healthcare is a privately owned PICS & WHO-GMP certified contract manufacturing and pharmaceutical development company in India
Position: Junior Executive – Regulatory Affairs
We are seeking a motivated Junior Executive – Regulatory Affairs to join our dynamic team. The ideal candidate will assist in obtaining and maintaining licenses, ensuring compliance with regulatory standards, and supporting the preparation of submissions for product approvals.
Key Responsibilities:
- Assist in planning, preparing, and executing regulatory submissions for new products and renewals.
- Ensure compliance with regulatory timelines for product registrations and renewals.
- Conduct gap analysis of registration dossiers to ensure adherence to government regulations.
- Collaborate with cross-functional teams (R&D, Quality Control, Manufacturing) to compile necessary documentation.
- Stay updated with regulatory guidelines, standards, and promotional regulations.
- Communicate regulatory updates and potential issues proactively to the manager.
- Support continuous improvement of regulatory processes and documentation systems.
Requirements:
- Education: B.Pharm / M.Pharm (Preferred: Specialization in Formulation & Development, Pharmaceutical Technologies).
- Experience: 1-3 years in Regulatory Affairs, preferably in Solid Oral Dosage Forms.
- Experience in Quality Control (QC) or R&D will be an added advantage.
- Strong understanding of regulatory guidelines (CDSCO, USFDA, EMA, etc.).
- Excellent analytical and documentation skills.
- Ability to work independently and collaboratively in a fast-paced environment.
Why Join Us?
- Opportunity to work in a growth-oriented pharmaceutical company.
- Exposure to global regulatory standards and compliance processes.
- Collaborative work environment with learning and career advancement opportunities.
