Regulatory Affairs Specialist
Our global Pharmaceutical client based in Hertfordshire is searching looking for a Regulatory Affairs Specialist to join their team on a 6-month contractual basis.
This exciting and global client helps to transform the lives of millions of both human & animal patients in the UK by providing innovative medicines, vaccines, and services. They invest heavily in the professional development of staff whilst also encouraging a healthy work/life balance.
This contract position will involve supporting the product portfolio, and will mostly involve typical lifecycle maintenance including submission of variations, renewals, labelling changes and MAH Transfers to the MHRA, as well as implementation and updates to the Company’s systems.
Roles and responsibilities as a Regulatory Affairs Specialist
- 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.
Qualifications, Skills & Experience required as a Regulatory Affairs Specialist
- 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, 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.
- Excellent verbal and written communication skills, with the ability to interact with a wide range of internal and external stakeholders, including the MHRA.
If this role interests you and you have similar experience, please apply today for more information.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
South East England
Located in the South East of England in commutable distance from Central London, this position would suit both local candidates and those wishing to commute from the city. We are looking for a
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