Job Description
Executive : Europe/UK/Australia/New Zealand Markets
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/Recent Zealand and maintains accurate regulatory records, and helps address emerging regulatory requirements under the guidance of senior team members.
Job Responsibilities
- 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.
Key Interfaces/Interactions
Internal Interfaces (Other than Direct Reports)
- Regulatory Affairs teams
- QA, QC, Manufacturing, Supply Chain, Medical Affairs, Commercial