Regulatory Affairs Officer, Pharmaceutical
Location: Home-based with occasional site visits.
Salary: Upto £28,000
Additional: Company laptop provided, company pension
Our Client, a Pharmaceutical Regulatory Specialist company - part of a very well-known pharmaceutical group; is looking to recruit for an RA Specialist with one to two years' experience. The successful Candidate will be giving the autonomy to grow and succeed. Given this company is in its infancy they will be offered fast career progression and will learn invaluable skills.
- Supporting the Head of Regulatory services for existing product portfolio and future product opportunities for medicinal products and medical devices- submissions and retrieval of analytical/manufacturing process data to support MAA
- Assist the PV team when required in relation to medical information queries, upload of approved product information to the eMC & ensure that additional risk minimisation measures required for a product are implemented (e.g.- additional follow up)
- Support audit preparation activities for department and of external vendors
- Assist in performing gap analysis
- Validate that product packaging is updated and maintained in accordance with product licences & international territories which may include the review of artwork for product packaging.
- Involvement in regulatory team meetings and manage assigned tasks with regular updates to the team
- Ensure that planning, preparing, tracking, and storing submissions to regulatory agencies are regularly updated and used.
- Maintenance of new & existing Marketing Authorisations registered via National and potential Material requirement planning.
- Communicate efficiently with key stakeholders both internally and externally- building a good relationship with them!
- Ensure familiarity with the company's product range and keep up to date with the company's regulatory standards and legislation for both UK and EU. As well as ensuring quality standards are consistently met and submissions are made accordingly.
- For both national and mutual recognition procedures prepare, compile, and submit a range of regulatory applications
- Liaise with various departments including Company Engineers and the Procurement Team to create, maintain and implement approved artwork drafts
- Report to the QPPV any updates on regulatory applications
- Liaise with the finance department with arrange payment fees to MHRA and other authorities when required
- Review and update SOPS to ensure they comply with applicable legislation with the UK & EU
- Actively seek to minimize risks to the business, Manage and alert risks via the Regulatory and Quality Manager
- BSc in a life science, healthcare, or pharmaceutical discipline
- Knowledge of national and MRP in the UK/EU
- Experience within RA within either Pharmaceutical or Medical Device
- Excellent understanding of analytical & manufacturing sciences in the pharma industry
- Experience or preparing and submitting post-marketing regulatory applications to the MHRA is a must (variations, renewals, post-marketing commitment submissions, PSURs)
- Experience of artwork type I and type II
- Experience of writing and updated product information documents to an excellent standard. This will include development of labelling & leaflet artworks.