Senior Director, Regulatory

1 week ago

UK, UK, United Kingdom Meet Full time

Exciting Career Opportunity: Global Regulatory & Operations Senior Director


Are you ready to lead and innovate in the dynamic world of Regulatory Affairs?

We are seeking a visionary Global Regulatory & Operations Senior Director to join our forward-thinking team.


This pivotal role involves overseeing Regulatory Affairs (RA) Operations, including global regulatory efforts, regulatory systems management, vendor coordination, process optimization, and data analytics.


Role and Responsibilities;


  • Ensure continuous compliance of RA operations across diverse regulatory landscapes in the EU and Canada.
  • Oversee RA delivery across multiple countries, leveraging both internal expertise and external vendor resources.
  • Drive RA operations to meet business requirements while adhering to budgetary constraints.
  • Develop and execute a robust RA data management strategy, providing valuable insights to internal and external stakeholders.
  • Uphold data quality standards and compliance protocols, overseeing stakeholders responsible for data entry and maintenance.
  • Ensure the integrity and efficacy of RA data analytics and reporting, facilitating informed decision-making on vendor performance, budget allocation, and compliance measures.
  • Lead the strategic management of all RA systems, from conception to implementation and maintenance, ensuring alignment with business objectives and budgetary guidelines.
  • Craft and communicate a compelling RA systems strategy to senior management, securing buy-in and support for implementation plans.
  • Proactively evaluate emerging technologies for potential integration into RA operations, driving continuous improvement and efficiency.
  • Monitor regulatory changes, assessing their impact on operations and devising strategies to mitigate risks and capitalize on opportunities.
  • Manage the global RA vendor strategy, overseeing vendor performance to ensure alignment with business needs, compliance standards, and budgetary goals.


What You'll Bring;


  • BSc degree in life sciences.
  • Extensive experience as a regulatory professional.
  • Proven track record in leading Regulatory Operations.
  • In-country or above-country RA experience in the EU or Canada.
  • Experience in vendor oversight and outsourcing delivery models.
  • Strong leadership and problem-solving skills.
  • Excellent communication skills with the ability to engage senior leaders effectively.
  • Effective collaborator with a strong customer and stakeholder focus.
  • Excellent knowledge of regulatory systems, regulatory systems direction, and systems guidelines.
  • Experience in managing and leading local regulatory delivery.
  • Ability to assess emerging industry trends and ensure incorporation of industry best practices in RA data, systems management, and operations.


What We Offer in Return;


  • Flexible benefits package
  • Opportunities for learning and development
  • Collaborative, inclusive work environment


Diversity and Inclusion;


We are committed to building an inclusive environment where people can thrive, grow, and achieve their full potential.

We believe this isn’t just the right thing, but also the smart thing to do, as we focus on making a positive difference for our customers and their patients.


Join Us;


If you are ready to make a significant impact in the healthcare industry and lead a team towards excellence in regulatory operations, we want to hear from you.

Apply now and take the next step in your career with us

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