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Senior Global Regulatory Labelling Manager

Hertfordshire   •  Negotiable  •  Permanent, Full time


Senior Global Regulatory Strategic Labelling Manager

Hertfordshire (UK) Hybrid

Global Regulatory Strategic Labelling Manager opportunity working for a global pharmaceutical company. The business specialises in neuroscience as well as having an established Oncology portfolio alongside a range of other products.

As a Senior Global Regulatory Strategic Labelling Manager, you will be responsible for the maintenance of the Company Core Data Sheets (CCDS) and product labelling. Including leading cross-functional meetings related to labelling.

Responsibilities

-Responsible for managing labelling strategy and timelines, attending kick-off meetings and managing the development of communication plans, risk strategies and escalations for the global labelling development through to post-marketing regulatory submission/approval strategies.

- Coordinate and lead cross-functional teams in the development and lifetime maintenance of the TPP, CCDS and Country Product Information (CPI) and CPI components for assigned products/projects.

- Maintain knowledge regarding key labelling requirements worldwide and stay current with labelling guidelines and regulations on a global basis.

Requirements

-Bachelor’s degree or higher in Life Sciences or equivalent

-Previous regulatory labelling strategy experience including involvement in strategy meetings.

-Previous experience working closely with the Company Core Data Sheet (CCDS).

-Experience with National legislation (CRP, DCP, and MRP) and regulations related to Human Medicine.

The role also comes with an excellent benefits package such as a car allowance, bonus of up to 15%, private dental care, a generous Pension plan, life assurance 4x salary, health insurance and 26 days of holiday.

If you are interested in this role or would like more details please email your CV to lucy.kirkaldy@cpl.com

  • Agency: Cpl Life Sciences
  • Reference: JO-2212-507270
  • Posted: 3rd January 2023
  • Expires: 31st January 2023

Cpl Life Sciences

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