Regulatory Affairs Specialist
4 weeks ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at ProductLife Group in the United Kingdom.
Key Responsibilities- Provide guidance and support to clients regarding regulatory submissions and activities in the UK.
- Contribute to the development of PLG's local UK Regulatory Affairs presence, taking responsibility for new regulatory activities related to the UK for several clients.
- Assist with the preparation of Marketing Authorization Applications (MAAs) and post-approval applications, including Type IA, Type IB, Type II, Renewals, MAH Transfers/COAs, and Technical/Site Transfer Applications.
- Manage artwork generation, labelling, and creation/update of product information, including review of packaging texts, format review of Summary of Product Characteristics, Patient Information Leaflets, and labelling (e.g., QRD compliance check).
- Respond to internal requests for technical and/or regulatory information and ensure compliance with all regulatory processes, in readiness for both internal and external audits.
- Monitor and maintain up-to-date knowledge of national and European guidelines/legislation and use a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data.
- Perform general regulatory administration duties and compliance requirements, document and track regulatory submissions and regulatory authority approval, and contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services.
- At least a Bachelor's Degree in Life Sciences, ideally a Pharmacy Degree.
- At least 5 years of experience in RA in a Pharmaceutical Company or Service Provider.
- UK LifeCycle Maintenance (LCM) experience, ideally EU LCM experience as well.
- Experience in regulatory lifecycle maintenance activities for drug products (Renewals, PI updates, technical variations) in the UK and ideally in the EU.
- Knowledge of UK regulation for pharmaceuticals (NCE, Biologicals and Biotech), Medical Devices, Combination products and Cosmetics.
- Strong computer skills, including MS Office applications, data and document management systems.
- Excellent communication, organizational, and interpersonal skills, with the ability to work well within a team and autonomously.
- Ability to prioritize different workloads/multi-task, process orientated with good attention to detail, and solution-driven.
ProductLife Group provides world-class regulatory outsourcing and consulting services for the global life sciences industry. Headquartered in Paris, ProductLife Group has offices in countries across Europe, the Middle East, Asia, Africa, Latin America, and North America.
We are a global industry leader, thanks to the firm's driven and talented employees, who are always motivated by a supportive team environment as well as opportunities to learn and to grow professionally.
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