Executive - Regulatory Affairs

Location : Taloja / Mahape

Desired Experience : 5 to 8 years Regulatory Affairs experience

Education : Masters in Pharmacy, Life Sciences, or related field

Role Overview :

The Regulatory Affairs position supports the life cycle management and business continuity of pharmaceutical products in Regulated markets by preparing, updating, and submitting regulatory documents for RUP, variations, and post-approval changes. The role ensures compliance with country-specific regulations for Europe/UK/Australia/Current Zealand and maintains accurate regulatory records, and helps address emerging regulatory requirements

under the guidance of senior team members.

Overall responsibility :
Assist in compiling, reviewing, and submitting regulatory dossiers for renewals, variations, RUP and other life cycle events.
Quality review of the required submission documents by providing technical input during initial review of the change proposal to ensure minimal queries or no queries during variation filing.




Maintain and update regulatory tracking systems/databases for submissions, approvals, and renewals.
Ensure quick turnaround time for replying to deficiencies received on EU/UK/Australia/NZ variations
To prepare consolidated dossier for filing RUPs and Duplicate dossier in the EU market.
Ensuring a regular follow up, quality review and compilation of documents received from stakeholders
Coordinate with various internal teams for regulatory submissions for the required submission documents .
Track and report on regulatory submission timelines and commitments.
Stay updated on regulatory changes and guidances in EU/ UK /Australia/NZ markets
Compliance to the approved dossier
Preparation and review of approval packages for the 4 markets
Attending meeting with stakeholders to provide regulatory inputs for the proposals received
Communicate with regional teams on regular basis.

📌 Executive Regulatory Affairs Navi Mumbai
🏢 Glenmark Pharmaceuticals
📍 Navi Mumbai