Regulatory Affairs Specialist
- Employer
- Therakind Ltd
- Location
- London (North), London (Greater)
- Salary
- Competitive
- Start date
- 28 Jun 2022
- Closing date
- 28 Jul 2022
View more
- Discipline
- Regulatory Affairs
- Hours
- Part Time
- Contract Type
- Permanent
- Experience Level
- Management
Job Details
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.
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
- 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
- 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
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.
Qualifications: Bachelor of Science
Location: North London
Start Date: As soon as possible
Salary: Competitive
Please send CV and cover letter to vacancies@therakind.com
Company
Therakind is a specialty pharmaceutical company focussed on developing niche medicines in difficult-to-treat markets including paediatric and geriatric patient groups and those suffering from chronic illness.
We have an innovative approach to medicine design and we are passionate about delivering life changing medicines for all.
Our expertise is the ability to design, develop and take new formulations to regulatory approval and beyond.
With a strong track record in the research and development of innovative medicines and drug delivery systems, our projects are designed specifically to take into account the pharmacodynamics and pharmacokinetics of difficult-to-treat patient groups.
Our clinical programmes are significantly de-risked compared to traditional biotech and pharma models by reformulating existing, approved products with proven safety and efficacy profiles, resulting in specially designed medicines to maximise efficacy and ease of use and thereby improve treatment adherence and disease management.
We are committed to recruiting, developing, retaining and rewarding highly motivated people who are talented, creative and focussed on delivering excellence.
- Website
- http://therakind.com/
- Telephone
- +44 (0)20 8346 6035
- Location
-
314 Regents Park Road
Finchley
London
N32JX
GB
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