A small private pharmaceutical company that creates, develops and improves speciality medicinal products is currently recruiting for a part-time Regulatory Affairs Specialist to join their team.
Based out of their North London office with potentially some flexibility for working from home, you will carry out a range of regulatory activities. The ideal candidate will have experience in medicinal product, device and combination product requirements. General pharmaceutical development knowledge and experience of both clinical trial and marketing authorisation applications would also be of relevance.
This role will suit someone who wants to join a small hard-working team and take a proactive role in all aspects of regulatory affairs.
- Manage the life-cycle maintenance of existing MAs
- Review and quality check regulatory dossiers (marketing and clinical trial stage) and documents (eg, protocols, IBs, PSMF, PSUR)
- Preparation of responses to questions from Regulatory Agencies
- Preparation, maintenance and quality check of Product Information e.g. SmPC, PIL, labelling, artwork
- Ensure projects are conducted in accordance with the latest ICH-GXP guidelines and legislation
Skills / experience required:
- Degree in Life Sciences
- 10 years UK/EU regulatory affairs experience
- Experience of EU/US authorisation procedures, including devices
- Fluent in both verbal and written English
- Meticulous attention to detail
- Adaptable and flexible within a team
- Candidates must be entitled to work in the UK
- Proven record as an accomplished Regulatory Affairs Associate
- Experience of EU central authorisation procedures
- Experience of US regulatory procedures/documentation
- Language skills in other European languages
- Excellent communication and time management skills
- Demonstrable track record for effective relationship building with colleagues and external collaborators, in addition to strong management skills.
Qualifications: Bachelor of Science
Location: North London
Start Date: As soon as possible
Please send CV and cover letter to #removed#