Executive - Regulatory Affairs

Job description

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/New 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.