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Senior Regulatory Affairs Manager

2 months ago

London, Greater London, United Kingdom Clinical Professionals Limited Full time
Job Summary

We are seeking a highly experienced and skilled Senior Regulatory Affairs Manager to lead our global labelling strategy and operations. As a key member of our Regulatory Affairs team, you will be responsible for providing expert regulatory knowledge and guidance to ensure compliance with healthcare industry regulatory requirements.

Key Responsibilities
  • Develop and implement global labelling strategies and processes to ensure compliance with regulatory requirements.
  • Lead and oversee the creation and maintenance of labelling documents, including Company Core Data Sheets and local labelling deliverables.
  • Chair cross-functional Global Labelling Committee and Labelling Working Groups to manage decision-making processes for labelling updates.
  • Design and implement strategies for the creation of a dedicated Global Labelling function.
  • Develop, improve, implement, and document best-in-class labelling processes, metrics, and templates.
  • Liaise with other Regulatory Affairs functions to ensure labelling updates are submitted and implemented.
  • Monitor consistency between local labelling documents and Company Core Data Sheets, and ensure exceptions are documented through standard process.
  • Provide strategic interpretations of labelling regulations and guidelines in a range of markets, including the US and EU.
  • Ensure compliance and performance of labelling processes in accordance with departmental KPIs.
  • Input into requirements for tools and systems required for the compliant management of labelling documents.
Requirements
  • Minimum of a Bachelor's Degree, preferably in a Scientific or Life Sciences Discipline. A PhD is desirable but not a must.
  • Significant Regulatory Affairs Labelling experience, including direct experience with CCDS, Core Product Information, and local labelling in a range of markets, including the US and EU.
  • Demonstrates subject matter expertise in labelling and labelling governance.
  • A strategic labeller with expertise in both developing and marketed labels in global regions.
  • Experience leading labelling professionals and preferably a global labelling team.
  • Experience with label development, including TPP.
  • Experience developing, implementing, and operating global labelling processes for a pharmaceutical company with worldwide product licenses.
Desirable Skills
  • Previous experience in a big pharmaceutical environment, with a sound understanding of the complexities in this environment.
  • Strong interpersonal skills, ability to forge connections and to influence stakeholders at all levels, in all regions.
  • Ability to clearly explain labelling concepts to senior stakeholders and Regulatory Affairs colleagues globally.
  • Ability to identify problems and their solutions, as well as driving them to resolution, delegating where necessary to achieve results.
  • Ability to learn new technologies, tools, and systems quickly – experience with Veeva RIM Submissions and Registrations Vault desired.