Senior Regulatory Affairs Director for Global Labelling

1 week ago


London, Greater London, United Kingdom CPL Healthcare Full time

Job Summary:

We are seeking a highly experienced Senior Regulatory Affairs Director to lead our global labelling strategy. This is a critical role that requires strong leadership and regulatory expertise to ensure compliance with healthcare industry regulations.

About the Role:

  • Lead the development of a comprehensive global labelling strategy, ensuring alignment with regulatory requirements and company goals.
  • Directly oversee the maintenance and development of Controlled Correspondence Document Sets (CCDS) and local labelling deliverables for regulatory filings.
  • Chair cross-functional committees to manage the decision-making process for labelling updates to established products.
  • Design and implement strategies for the creation of a dedicated global labelling function, driving best-in-class processes and metrics.
  • Liaise with other Regulatory Affairs functions to ensure timely submission and implementation of labelling updates.
  • Provide strategic interpretations of labelling regulations and guidelines in various markets, including the US and EU.
  • Ensure compliance and performance of labelling processes in accordance with departmental KPIs.

Requirements:

  • Bachelor's Degree in a Scientific or Life Sciences Discipline, preferably with significant experience in Regulatory Affairs Labelling.
  • Demonstrated subject matter expertise in labelling and labelling governance, with direct experience in CCDS, Core Product Information, and local labelling.
  • Strong leadership skills, with experience leading labelling professionals and a global labelling team.

Key Skills:

  • Excellent communication and interpersonal skills, with the ability to influence stakeholders at all levels.
  • Ability to clearly explain complex labelling concepts to senior stakeholders and Regulatory Affairs colleagues globally.
  • Strategic problem-solving skills, with the ability to drive issues to resolution.

Compensation and Benefits:

The estimated salary for this position is $140,000 - $160,000 per annum, depending on experience. We offer a comprehensive benefits package, including health insurance, retirement plans, and paid time off.



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