Regulatory Affairs Manager

Regulatory Affairs Manager

Mundipharma

Cambridge, United Kingdom

Role and Responsibilities

• Provide regulatory expertise to ensure quality delivery from regulatory vendors.
• Support regulatory intelligence activity and regulatory project delivery.
• Regulatory operational management within the regulatory strategy and labelling team and with the country cluster leads.
• Regulatory expertise and management and coordination of regulatory activity with regulatory vendors for major submissions including submissions that are multi product and multi region and any associated artwork changes.
• Management and coordination of regulatory activity to support ongoing project delivery such as scientific advice and strategy planning and health authority inspections
• Support regulatory intelligence activity including monitoring and interpretation of new guidance and coordinating any regulatory activity required.
• Oversight of regulatory ancillary document team and regulatory sharepoint and resources.
• Support ongoing regulatory activity with management of issue resolution, change control, deviations and SOP updates as required. Support with generation of regulatory project updates.

What you’ll bring

• Background in Regulatory Affairs.
• Previous Pharma regulatory affairs management experience.
• Previous experience covering EU markets would be beneficial.
• Ideally have experience in various therapeutic areas - Pain and Respiratory would be beneficial.
• Ability to deliver independently.
• Strong negotiation and problem-solving skills, organized, self-motivated, driven with a positive attitude.
• Excellent communication skills and ability to engage within the organisation effectively.
• Strong collaborator with excellent stakeholder and customer focus.

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