Cadila Pharmaceuticals Limited, one of India’s leading research-driven pharmaceutical companies, is hiring for the position of AGM / Manager – Regulatory Affairs (Formulation) at its Dholka facility. This is an excellent opportunity for experienced RA professionals seeking senior-level leadership roles in formulation regulatory strategy, submission management, and global compliance.
If you have strong expertise in regulatory documentation for regulated and semi-regulated markets, this opening is ideal to advance your pharmaceutical regulatory career.
About the Role
The Regulatory Affairs (Formulation) Manager/AGM will play a key leadership role in handling end-to-end regulatory activities, dossier preparation, lifecycle management, and coordination with global agencies for timely product approvals.
Key Responsibilities
- Lead Regulatory Affairs – Formulation for domestic and international submissions
- Review and compile CTD/eCTD dossiers, technical documents, and product variation files
- Ensure compliance with global regulatory guidelines such as USFDA, EMA, MHRA, WHO, and ROW authorities
- Coordinate with Formulation R&D, QA, QC, Packaging Development, and Manufacturing teams
- Manage product registration, renewals, updates, and regulatory queries
- Monitor changes in international regulations and implement required updates
- Support audits, regulatory inspections, and internal compliance initiatives
- Ensure timely completion of regulatory submissions for new product launches
- Guide and mentor RA team members for smooth operational execution
Qualifications
- M.Pharm / M.Sc in Pharmaceutical Sciences
- Minimum 12 years of experience in Regulatory Affairs (Formulation)
- Strong understanding of formulation development, dossier preparation, and global regulatory pathways
- Excellent communication, documentation, and cross-functional coordination skills
Benefits
- Opportunity to work with one of India’s most trusted pharmaceutical companies
- Leadership-level responsibility with career growth
- Competitive compensation (Industry Standard)
- Exposure to global regulatory markets
How to Apply
Interested and eligible candidates can apply using the contact details below:
📧 Email: savitri.thakor@cadilapharma.com
