Senior Regulatory Affairs Executive

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

• Strong 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 removed]

contact - [phone removed] (Ext 723).

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

Thanks & Regards,

Dipika Mali

Human Resource

Titan Laboratories Pvt Ltd.