Senior Regulatory Affairs Officer

 

ABOUT THE ROLE

RPP comprises two legal entities, RPH Pharmaceuticals AB and RPH Pharma Ltd, and operates as part of the Recipharm group. The company collaborates with both internal and external CDMOs to develop generic pharmaceutical products with the aim of securing market authorisations. These authorisations are, in some cases, licensed to third parties, enabling RPP to generate revenue through the sale of products manufactured by CDMOs to external partners.

In addition, RPP conducts direct product sales in the UK and EEA, supported by a third-party logistics providers and distributors

We are 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

Key Responsibilities

  • Lead and contribute to the development and execution of regulatory strategies for both new and existing products across UK and EU territories
  • Provide regulatory support throughout the full product lifecycle, including early development, registration, post-approval maintenance, and lifecycle management activities
  • Contribute to the development and implementation of regulatory strategic and tactical plans, ensuring alignment with business objectives and evolving regulatory requirements
  • Act as a regulatory lead for development projects, providing guidance on CMC requirements to support successful product development and timely submissions

CMC & Submission Activities

  • Lead the preparation, review, and approval of CMC (Module 3) documentation, using primary source data
  • Oversee and author high-quality Marketing Authorisation Applications (MAAs) in eCTD format for UK and EU via:
    • National procedures
    • Decentralised procedures (DCP)
    • Mutual Recognition procedures (MRP)
  • Provide strategic oversight and hands-on involvement in the preparation, review, and submission of:
    • Variations (Type IA, IB, II)
    • Renewals
    • Labelling/artwork updates (Article 61.3)
    • Batch Specific Variations/Release (BSV/R), where applicable

Lifecycle Management & Compliance

  • Ensure all product information (SmPC, PIL, labelling) remains in-line with the reference product and compliant with current EU/UK regulatory requirements (e.g. QRD templates, excipient guidelines)
  • Lead the preparation and review of responses to regulatory authority questions, ensuring timely and high-quality submissions
  • Maintain oversight of Regulatory Information Management Systems, ensuring accuracy of licence data (e.g. MA numbers, manufacturers, ATC codes, excipients)

Business Development & External Engagement

  • Lead and support in-licensing and out-licensing activities, providing regulatory expertise during negotiations and partnership discussions
  • Perform regulatory due diligence for potential business opportunities, including assessment of dossiers, development status, and regulatory risks
  • Foster strong customer and partner engagement, acting as a key regulatory contact for external stakeholders, partners, and health authorities

SKILLS AND EXPERIENCE

  • Minimum of 5 years’ experience in Regulatory Affairs within the pharmaceutical industry
  • Demonstrated experience in authoring Module 2 and 3 documentation for MAA and variations.
  • Extensive experience in UK and EU (MRP, DCP, CP) regulatory procedures is essential.
  • Proven experience in regulatory strategy, submissions, and lifecycle management
  • Ability to efficiently locate, interpret and apply regulatory information from primary sources such as EMA, CMDh, EDQM, MHRA, HPRA and FDA.
  • Experience supporting product development from a regulatory perspective.
  • Involvement in licensing activities and regulatory due diligence.
  • Prior experience in line management or mentoring is advantageous.
  • Exposure to international markets (e.g. US, ROW, emerging markets) is
  • Experience of eCTD publishing is

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 who based in the UK citizenship and have a valid work/residence permit and permanent residence in the UK.

 

 

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