Job Title: Regulatory Project Manager
Location: India (Remote)
Contract duration: until December 2026
Hours: 155 per month
Start: ASAP

Company Overview:

Apsida Life Science is partnering with a leading global clinical research organization that provides end-to-end clinical development and regulatory consulting services to pharmaceutical, biotechnology, and medical device companies. With a solid global presence, the organization supports clients across the product lifecycle, delivering expertise in clinical research, regulatory affairs, pharmacovigilance, and market access to help bring cutting-edge therapies to patients worldwide.

Key Responsibilities:
Responsible for the regulatory management (delivery and maintenance)of clinical assets and MAs for a portfolio of products for Ireland and UK
Is the primary interface with the local regulatory authorities
Ensure product information is compliant with MA. Ensures that the company’s product Summary of Product Characteristics (SPCs)



and Patient Information Leaflets (PILs)/ labeling are compliant with MA and with regulatory requirements
Co-ordinates national input into responses to regulatory questions and regulatory commitments, ensuring these are in alignment with regulatory requirements and agreed strategy and timelines.
Responsible for the local management of product registration documents in regulatory databases and repositories.
Manage regulatory agency correspondence in accordance with company procedures
Notify to Regulatory agencies product quality and safety issues in an expeditious manner in accordance with company procedures
Completes Marketing Authorisation Holder (MAH) review of Periodic Quality Reviews for all registered products in responsible portfolio for which the company’s Ireland is MAH
Effective planning of regulatory activities for portfolio
Provides considered regulatory advice, leadership and expertise to brand teams and to other regulatory and cross functional groups.
Co-ord

📌 Regulatory Project Manager Kota
🏢 Apsida Life Science
📍 Kota