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 strong 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