Sr. Executive Regulatory Affairs

Job Description

Harman Finochem is seeking a meticulous and experienced Senior Executive - Regulatory Affairs to join our team. In this role, you will be responsible for the planning, review, and submission of regulatory dossiers for export markets, with a primary focus on Europe and the US. If you have a strong background in CTD/eCTD submissions, managing post-approval changes, and resolving technical queries, we encourage you to apply! Key Responsibilities Dossier Planning & Submission: Plan, review, and ensure the timely submission of CTD/ACTD/eCTD (Common Technical Document/ASEAN Common Technical Dossier/electronic Common Technical Document) for export markets, specifically focusing on Europe and the US . Registration Management: Handle Registration, Re-registration, and post-approval change applications for various export markets. Query Resolution: Efficiently resolve technical queries related to product registration, re-registration, and post-approval changes from regulatory authorities. Internal Coordination: Conduct effective follow-up and coordination with internal stakeholders, including R&D, Production, and Quality Control, to gather necessary documentation and information. Document Review: Thoroughly review technical documents to ensure accuracy, completeness, and compliance with regulatory requirements. Artwork & Packaging Review: Review artwork and pack inserts for compliance with regulatory guidelines and approved product information. Safety Reporting: Prepare and submit Product Safety Update Reports (PSURs) as per regulatory mandates. Required Skills & Experience Proven experience in Regulatory Affairs within the pharmaceutical industry. Hands-on experience with CTD/ACTD/eCTD formats and submissions . Specific experience working with European and US markets is highly preferred. Expertise in managing product registration, re-registration, and post-approval change applications. Demonstrated ability to resolve technical queries from regulatory bodies. Strong analytical skills for reviewing complex technical and regulatory documents. Experience with artwork and pack insert review. Ability to prepare and submit Product Safety Update Reports. Excellent communication and coordination skills for effective stakeholder interaction.