Regulatory Affairs Manager LCM

Harefield, England, United Kingdom · Regulatory Affairs

Description

MAIN PURPOSE:

The Regulatory Affairs Manager is responsible for developing the regulatory vision for assigned products in order to deliver against Norgine’s global product strategy and vision. As the regulatory subject matter expert the RA Manager will:

The RA Manager will develop regulatory strategies to deliver business goals and advise Regulatory Change Leads how to achieve changes to registered details in the most efficient and effective way to secure approval from competent authorities.

The RA Manager will work in close collaboration with Regulatory leadership and Regulatory Change Leads to keep good oversight on the progress of activities related to their assigned portfolio of products and will communicate clearly and effectively with key stakeholders in other departments to ensure that long term plans for regulatory activity are visible and changes are proactively communicated.

KEY RESPONSIBILITIES & ACCOUNTABILITIES:

Requirements

Minimum BSc and MSc or PhD or PharmD or M.D. in science or healthcare preferred or equivalent relevant experience

Must have demonstrable experience managing product portfolios within a Regulatory Affairs global position.

Considerable regulatory experience with EU regulatory requirements and processes (MRP, DCP and CP) for post approval activities. Experience with AU and NZ preferred

Competencies

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