Role & responsibilities
- Prepare review and submit rewarding dossier (DMF, CEP, CTD/ECTD, Korean DF, Brazil DMF (Anvisa Technical packages) for various markets.
- Handled deficiency responses, query management and correspondence with regulatory authorities & Customers.
- Maintain and update regulatory documents, including specification, analytical methods, process description and stability data.
- Co-ordinate with QA, QC, production R & D and supply chain collection of required documents and data.
- Truck submission timelines, approval, renewals and annual reports.
- Support preparation for regulatory inspection and follow up actions.

Preferred candidate profile
- Solid communication and coordination skills




- Good documentation and record management ability
- Sound problem-solving and analytical skills
- Effective follow-up and timeline management

Qualifications (must-have and preferred) & Experience:
- M. Pharm
- 8+ Years in Regulatory Affairs

Interested candidate can mail CV on below contact details -

Contact details -

Mail ID - [email protected]

contact - 022 - 6785 7000 (Ext 723).

If you have good references you can share on above details.

Thanks & Regards,

Dipika Mali

Human Resource

Titan Laboratories Pvt Ltd.

📌 Senior Regulatory Affairs Executive (Navi Mumbai)
🏢 Titan Laboratories
📍 Navi Mumbai