Title: Regulatory Project Manager
Location: Ireland and UK Regulatory Affairs – Fully remote
Duration: 6-12 months

Company Overview

Apsida Life Science is currently partnering with an organisation dedicated to community-based clinical trials, ensuring excellent standards of participant care and a smooth transition from the hospital to the home in accordance with study protocols, clinical practice regulations, and ICH-GCP requirements.

Responsibilities:
- Responsible for the regulatory management (delivery and maintenance) of clinical assets and MAs for a portfolio of products for Ireland and the UK
- 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 regulatory agencies promptly of product quality and safety issues ex in accordance with company procedures
- Complete 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 groups.

Qualifications:
- Graduate/PhD level or equivalent – Life sciences
- Experience in the pharmaceutical industry, including regulatory experience
- In-depth understanding and practical experience of national or/and EU regulations, guidelines and working practices and of the regulatory issues rele

📌 Regulatory Project Manager (India)
🏢 Apsida Life Science
📍 India