CMC Regulatory - Head of Department – Approved Small Molecule

Discipline: Regulatory Affairs
Job type: Permanent
Contact name: Katie Dunbar

Contact email: katie.dunbar@rbwconsulting.com
Contact phone: +44 1293 584 300
Job ref: 28110
Published: 2 months ago
Expiry date: 30 Sep 2023 11:59
A leading name in the pharma industry are seeking a leader for their newly-defined Regulatory CMC Small Molecule Post-Marketed department.

This is a critical position supporting this business area at a global level including the internal and external network. It is a highly visible and truly global role, leading a large team of regulatory experts supporting all CMC Regulatory activities of the established small molecule portfolio.

This portfolio is high-profile with innovation of the product pipeline a key focus, and many exciting and challenging projects. This position will be a member of the Global CMC Regulatory Leadership Team.

Key Responsibilities:
The position requires technical knowledge, but also interpersonal, influencing and communication skills to build solid relationships throughout the Company and beyond. The person in post must operate with significant autonomy, meaning the chance to drive improvements across a wide range of processes and products.
  • Representing Global CMC Regulatory, on Regulatory and Governance networks, providing and overseeing strategic direction and guidance.
  • Management of a multi-project/multi-function team, leading, influencing, and motivating staff
  • Management of the Change Control, OOS and supply issues activities within CMC Regulatory
  • Delivering and overseeing CMC Regulatory strategies for multiple projects, including communication of risk mitigation strategies to senior management.
  • Leading the CMC Regulatory strategy to support inspections, quality incidents and to ensure the continuation of supply.
  • Advising on regulations, guidelines and strategies related to manufacturing and registration of products, enabling efficient submissions and approvals of CMC regulatory submissions.

Profile/Experience:
  • Degree in Pharmacy, Chemistry or other related scientific discipline.
  • Proven experience in managing multi-project teams and resources.
  • Detailed experience of manufacturing and supply processes within the pharmaceutical industry.
  • Demonstrated ability to influence the global internal/external regulatory environment.
  • Project management and multi-tasking skills.
  • Demonstrated experience handling complex global CMC issues including confidence in risk management and decision making.
The role can either be hybrid from home and the Paris office, or remote in the EU or UK. This is a permanent role, with a negotiable salary and package designed to attract a suitable candidate.

If you wish to learn more, apply with your CV and you will receive a call with full detail prior to application. Alternatively, please contact Katie Dunbar +441273 952176 for more information.