Senior Regulatory Affairs Officer

ABOUT THE ROLE

RPH Pharmaceuticals, part of the Recipharm Group, is seeking a Regulatory Affairs professional to support the development, implementation and maintenance of regulatory strategies for new and existing pharmaceutical products across the UK and EU. The role involves hands-on preparation, review and submission of regulatory documentation throughout the product lifecycle, working within national, decentralised and mutual recognition procedures.

You will play a key role in ensuring regulatory compliance, maintaining high-quality submissions, and supporting interactions with regulatory authorities, while operating in line with Recipharm’s ethical standards, policies and governance requirements.

MAIN TASKS & RESPONSIBILITIES

  • Contribute to the development, implementation and monitoring of regulatory strategies and both strategic and tactical regulatory plans for new and existing products
  • Prepare, review and authorise CMC documentation (Module 3) using primary manufacturing source documents, including BMRs, BPRs, test methods, protocols and stability reports
  • Prepare, review and publish new Marketing Authorisation Applications (MAAs) in eCTD format for UK and EU territories via National, Decentralised and Mutual Recognition Procedures
  • For National, Decentralised and Mutual Recognition procedures, prepare, review, publish and submit:
    • Quality and Safety variations
    • Artwork
    • Marketing Authorisation renewals
  • Manage Batch Specific Variations/Release (BSV/R), where applicable
  • Update product information, including SmPCs and labelling, in line with current EU guidelines and requirements (e.g. QRD templates, excipient warnings)
  • Prepare, review, publish and submit responses to questions from regulatory authorities
  • Maintain accurate and up-to-date license information within the Regulatory Information Management System, including MA details, manufacturers, ATC codes and excipient lists
  • Carry out general administrative duties in support of the Regulatory Affairs function

SKILLS AND EXPERIENCE

  • Minimum of 5 years’ experience in Regulatory Affairs within the pharmaceutical industry
  • Excellent working knowledge of CMC documentation (Module 3) and regulatory dossiers
  • Strong understanding of current UK and EU regulatory legislation, guidelines and requirements, with the ability to apply them strategically and tactically to new registrations and post-approval submissions
  • Proven experience with Marketing Authorisation Applications and post-approval regulatory activities and submissions
  • Ability to efficiently locate, interpret and apply regulatory information from primary sources such as EMA, CMDh, EDQM, MHRA, HPRA and FDA
  • Experience providing regulatory input and advice to support UK and EU regulatory strategies

Core Skills

  • Ability to work independently with minimal supervision, as well as collaboratively within cross-functional teams
  • Strong organisational and time-management skills, with the ability to prioritise and manage multiple tasks simultaneously
  • High attention to detail and a structured approach to regulatory documentation
  • Excellent IT skills, with confidence using regulatory systems and standard office software

Qualifications

  • Degree in Life Sciences or a related discipline

 

WHAT WE OFFER/EMPLOYEE BENEFITS

Our core values of Respect, Reliability, Collaboration and Excellence shape every aspect of our work and our interactions with all our stakeholders. We seek individuals who are respectful, considerate and honest, value diversity and show integrity in their daily work. Our culture thrives on reliability, ensuring we consistently deliver on our promises and meet the expectations of our stakeholders through operational excellence. We believe in the power of collaboration, fostering an agile environment through teamwork and active listening. Our relentless pursuit of excellence drives us to deliver high-quality products and services, while maintaining a supportive and inclusive atmosphere where every team member is recognised and valued. Join us to be part of a community that is committed to mutual success and high standards.

 

LOCATION

This is a remote based role and open for applicants with EU/UK citizenship, or with a valid work/residence permit and permanent residence in the UK, Sweden, Germany, Italy, France, Spain, or Portugal where Recipharm has presence. 

Office space is available in UK and Sweden.

 

 

 

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