A RAS 2458365
General & Other, Other
£33,000 to £34,000 Per Annum
We specialise in the recruitment of high quality candidates in the Life Science sector. We have an excellent opportunity for a Regulatory Affairs Specialist, Export, to join a highly successful and ambitious Pharmaceutical Company which seeks to double its revenue within 3 years. It operates as a semi-autonomous business within an NHS Trust with its own Management Board.
They are seeking a skilled Regulatory Specialist who has significant experience in the implementation of Clinical and Regulatory solutions. The successful incumbent will be responsible for international submissions in line with the commercial export strategy and in liaison with the Commercial Team. They will be expected to deputise for the Head of Regulatory Affairs and attend Competent Authority, Distributor locations (overseas) when required.
Regulatory Affairs Specialist’s Primary Duties and Areas of Responsibilities
- Liaise with the Commercial Export Manager to ensure the regulatory aspects for exporting of TP products are fully assessed and are complied with.
- Liaise with the local distributor/agent to ensure the process is fully understood by both parties and liaise where necessary with the regulatory authority.
- Prepare project plans to support the submission of the product licences
- Co-ordinate and prepare reports to Regulatory Agencies in response to requests for further information after assessment of submissions.
- Responsible for the generation and submission of highly complex technical and scientific documentation to Regulatory Agencies to gain a Marketing Authorisation
- Responsible for reviewing licensing projects, and contributing to the product and device licensing planning process.
- Responsible for providing the regulatory affairs team with the necessary product knowledge to enable them to seek Marketing Authorisations.
- Develop and implement procedures for the submission of regulatory documents in eCTD (electronic common technical document) format on the MHRA/European Medicines Agency portal via specialist software eCTD Office.
- Develop and implement procedures for the electronic validation of regulatory submissions using specialist validator software (LORENZ eValidator).
Regulatory Affairs Specialist/ Knowledge, Skills and Experience
- Comprehensive knowledge of national and international licensing, pharmacovigilance and medical device certification processes and legislation.
- Experienced in licence application submissions via the decentralised and centralised routes within Europe and submissions outside of the EU to global regulatory agencies.
- Experienced in working with overseas regulators
- Comprehensive Computer/Keyboard and IT skills, including: Adobe Professional, Prisym, LIMS, Q-Pulse, eCTD Office Complier and submission software Professional.
- Minimum of 2 years’ experience of working within the Pharmaceutical Regulatory Industry and including overseas licensing in Middle East, Africa, Asia.
- Experienced in generics, branded pharma and exporting unlicensed 'Specials’overseas, desirable but not essential.
Regulatory Affairs Specialist’s Academic and Professional Qualifications
- Life Science Degree (BSc). A Masters, or higher level degree, in a Life Science discipline would be desirable, but not essential.
- A Business Management qualification would be desirable, but not essential.
- Fluent (technical level) in at least one other language from Middle East, Africa or Far East, is desirable, but not essential.
- TOPRA Membership and Chartered Status are also desirable, but not essential.