Sector: Life Sciences
Consultant: Josh Sidki
Salary: £40000 - £52000
Job Status: Permanent / part time
Regulatory Affairs Officer
North London, UK
A small private pharmaceutical company, that creates, develops and improves speciality medicinal products are currently recruiting for a full time / 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 with a focus on centralised applications. The ideal candidate will have experience in EU post authorisation life-cycle maintenance, including management of product information, and an understanding of pharmacovigilance. General pharmaceutical development knowledge and experience of clinical trial 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.
- Oversight of contracted out pharmacovigilance activities.
- 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
- 5 years UK/EU regulatory affairs experience
- Experience of EU authorisation procedures
- Fluent in both verbal and written English
- Meticulous attention to detail
- Adaptable and flexible within a team
- 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.
If you are interested in this position, then hit that “APPLY” button now, and I will be in touch if i feel your application & CV is suitable for the role.