Evolve
Regulatory Affairs Officer
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Regulatory Affairs Officer
Evolve are partnering with a leading supplier of specials and clinical trial medicines in the UK to recruit a Regulatory Affairs Officer. This is a fantastic opportunity to join a collaborative QA & Regulatory team, supporting regulatory submissions, product lifecycle management, packaging and labelling compliance, and interactions with the MHRA. If you're looking for a varied role where you can make a real impact, we'd love to hear from you.
This is a full time 12-month fixed term hybrid contract position working 2 days per week at our client’s head office in Leicester.
Why Apply?
- Excellent Salary & Benefits - A competitive starting salary of up to £50,000 DOE, plus exceptional bonus, private healthcare, pension, and much more!
- Collaborative Culture - Thrive in a supportive, people-focused environment.
- Career Advancement - Diverse development paths in an inclusive workplace that nurtures growth and progression.
Ideal Requirements for the Regulatory Affairs Officer
- At least 2 years proven experience in Regulatory Affairs within the pharmaceutical industry, with a strong track record of managing packaging and labelling updates and building effective relationships with regulatory authorities, including competent authorities.
- Strong knowledge of medicinal product packaging and labelling requirements, with a sound understanding of relevant regulatory guidance, including Title V of Council Directive 2001/83/EC.
- Hands-on experience with eCTD submissions and regulatory documentation, including marketing authorisation applications (MAAs), IMPDs and/or IND/NDA submissions.
- A solid understanding of quality systems, with experience implementing new processes and driving continuous improvements to enhance regulatory compliance and operational efficiency.
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Role Responsibilities for the Regulatory Affairs Officer
- Lead the end-to-end coordination of regulatory submissions, including preparing, submitting and maintaining eCTD sequences, while supporting variations and managing communications with regulatory authorities such as the MHRA.
- Drive regulatory strategy for innovative and established products, partnering with cross-functional teams to shape development plans and support key regulatory milestones, including marketing authorisations and scientific advice.
- Own product lifecycle regulatory compliance, coordinating updates to SmPCs, labels and packaging, ensuring robust change control processes are implemented and regulatory dossiers remain current.
- Collaborate with internal and external stakeholders to deliver successful regulatory outcomes, working closely with quality, operations, purchasing and clients while providing regulatory review and approval of marketing materials.
Recruitment Process
- 2 stage interview process
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Excited to learn more? Click apply or reach out to the Pharmaceutical recruitment team for full details!
Get to know your recruiter, Katie, on our website: https://www.evolveselection.com/the-team/team/katie-fisher
Application Process
Evolve Selection acts as a recruitment partner on behalf of our clients. All applications are reviewed by our specialist consultants and assessed against the specific requirements of the role. Suitable candidates will be contacted for an initial discussion before being introduced to the hiring client.
We appreciate every application; however, due to application volumes, we may not be able to respond to all candidates individually. If you have not heard from us within 3 working days, please consider your application unsuccessful for this particular role, however we may contact you regarding future opportunities that match your experience in line with our privacy policy.
Evolve is a leading recruitment and outsourcing organisation, operating within the Pharmaceutical, Healthcare, Medical Device and Life Science sectors.
Equal opportunities are important to us. We believe that diversity and inclusion are critical to our success as a company, We encourage applications from everyone, regardless of background, gender identity, sexual orientation, disability status, ethnicity, belief, age, family or parental status, and any other characteristic.
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