Senior Regulatory Specialist
Proclinical is currently recruiting a Senior Regulatory Specialist in London, this is also a remote opportunity. You will be expected to execute regulatory strategies for an established pharmaceutical organisation in the UK. You will oversee MHRA affairs across the organisation.
- Prepare and submit high quality regulatory filings for the UK affiliate to the MHRA.
- Support and action the regulatory end-to-end process to execute company and Brexit related activities.
- Maintain marketing authorisations (MAs) approved via National, Mutual Recognition/Decentralised and Centralised procedures.
- Generate and maintain prescribing information, patient information leaflets and packaging components, including artwork implementation and management
- Provide regulatory input to business stakeholders on potential product issues and deletions/divestitures for the respective product portfolio.
- Implement and communicate changes to relevant stakeholders, and ensure all compliance activities and company systems are correctly managed.
- Work as an effective member of the UK regulatory team, contributing with strong experience and understanding of the evolving UK regulatory framework.
- Able to work to stimulating deadlines and manage conflicting priorities with sound time-management skills.
Skills and Requirements
- BSc. Degree or higher (or equivalent qualifications/experience) in pharmacy or a life-science subject.
- 5+ years of working in a regulatory affairs role in the pharmaceutical industry is necessary with in-depth knowledge of EU/UK regulatory procedures and a comprehension of EU and UK Medicines Legislation.
- Experience of working in UK affiliate regulatory role, with preparation and submission of applications to and working with the MHRA.
- Able to work on own initiative and take be accountable for managing the day-to-day regulatory activities for a portfolio of products.
- Experience of working within electronic regulatory tracking databases and document/artwork management systems.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.