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