[ref. c20231517] Regulatory Affairs Officer - City of London

• 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.

Required Skills & Qualifications:

• 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.

Benefits:

• 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.