Apsida Life Science
Regulatory Project Manager
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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.
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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
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If you are interested in learning more, please reach out to Sweetness Zono at Apsida Life Science:
- Email: Sweetness.zono@apsida.com
- Website: www.apsida.co.uk
- Phone: +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.
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