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- Location: Middlesex, UK
- Job Type: Mon - Friday, Full-time
- Salary: £30,000p.a
We are seeking an experienced Regulatory Affairs Officer to join our dynamic Regulatory Affairs Team. This role involves managing regulatory applications such as licence, variations, and renewals for our UK/Ireland licence portfolio. The successful candidate will ensure that all regulatory submissions meet high quality standards and comply with relevant guidelines.
Day-to-day of the role:- Review, compile, and submit high-quality regulatory submission packages to the UK MHRA, Ireland HPRA, and other EU Regulatory Agencies where applicable, ensuring all submissions and responses are made within agreed timelines.
- Prepare and maintain product labelling and literature.
- Ensure licence maintenance and compliance with relevant guidelines and directives, including support and input on Product Quality Reviews.
- Maintain accuracy and completeness in all internal tracking tools and electronic databases.
- Work within the relevant change control system.
- Collaborate closely with various departments including Goods Inward, Printing, Production, Quality Assurance, Quality Compliance, Pharmacovigilance, and IT to ensure full compliance with Departmental and Company SOPs.
- Life Science Degree (Medical Science, Biomedical Science, Pharmaceutical Science).
- Experience in the pharmaceutical parallel imports industry and knowledge of UK, Ireland, and EU regulatory procedures pertaining to parallel import licensing.
- Excellent communication, organisational, and interpersonal skills.
- Ability to work under pressure and meet tight deadlines.
- IT literacy, with any experience using Microsoft Office, Adobe Illustrator, Prisym 360, and Nice Label Design.
- Experience with pharmacovigilance, GMP, GDP, and Quality systems would be advantageous.
- Opportunity to work in a leading company within the pharmaceutical sector.
- Competitive salary and career advancement opportunities.
- Dynamic and supportive work environment.
Interested? Don't wait apply today. We look forward to hearing from you.
