Regulatory Project Manager

Apsida Life Science · India

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 relevant to the portfolio.
• Knowledge of drug development process and regulatory affairs,
• Knowledge of the commercial and medical issues pertaining to the assigned portfolio, including an awareness of competitor products and activities
• Has an in-depth understanding of regulatory governance, medical and safety

If you are interested in learning more, please reach out to Sweetness Zono at Apsida Life Science:

Sweetness.zono@apsida.com

+44 (0) 744 134 2281

Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective, high-quality, and trusted recruitment service that puts the candidate journey at the heart of the recruitment process