1. Prepare and submit regulatory dossiers for new product registrations, variations, and renewals for Tablets, Capsules, Liquids, Ointments and Powders for Africa, CIS and LATAM countries.
2. Coordinate and manage the submission of regulatory documents (CTDs, eCTDs, dossiers, clinical trial applications) to the relevant health authorities.
3. Facilitate communication with health authorities, responding to queries, and ensuring compliance with regulatory timelines.
4. Ensure that all pharmaceutical products comply with regulatory requirements in target markets.
5. To ensure all the compliances before any regulatory audit and to represent the company during the regulatory audits.
6. Review product labeling, packaging, and advertising materials to ensure compliance with regulatory guidelines.
7. Maintain accurate and comprehensive regulatory files and documentation for products in compliance with regional regulations.
8. Monitor and assess regulatory trends, changes in legislation, and health authority requirements in target regions.
9. Identify regulatory pathways for new product launches and lifecycle management of existing products.
10. Work closely with R&D, Quality Assurance, and Manufacturing teams to ensure that the products meet regulatory requirements throughout the product development lifecycle.
11. Collaborate with marketing and sales teams to ensure that product claims and promotional activities align with local regulatory requirements.
12. Continuously track and evaluate changes in drug regulations, including GMP (Good Manufacturing Practice) and other relevant policies across various target countries.
13. Build and maintain strong relationships with key regulatory authorities in various target regions, including ministries of health, regulatory bodies, and industry associations.
14. Represent the company at regulatory meetings, conferences, and workshops related to pharmaceutical regulations.
Education, Experience and Skills Required:-
1. M. Pharm (Female Candidate Preferred).
2. 3 years of experience in Regulatory Affairs in Pharmaceutical Formulations unit desired.
3. Excellent communication skills.
Salary - 40,000 - 45,000 per month (CTC)
Job Types: Full-time, Permanent
Pay: ₹40,000.00 - ₹45,000.00 per month
Benefits:
Cell phone reimbursement
Health insurance
Provident Fund
Work Location: In person
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