Regulatory Affairs Officer
- Employer
- Seven Resourcing
- Location
- Finchley
- Salary
- £40000 - £52000/annum
- Closing date
- 8 Sep 2019
View more
- Sector
- Healthcare & Medical
- Hours
- Part Time
- Flexibility
- Set hours
- Contract Type
- Permanent
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Regulatory Affairs Officer
Permanent
Part Time
ASAP Start
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.
Responsibilities:
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:
Essential:
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
Desired:
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
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