Regulatory Project Manager

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:

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