Regulatory Affairs Manager

Regulatory Affairs Manager

Location: Cambridge, Hybrid - Open to remote working

Department: Regulatory Affairs

Job type: Permanent

Join us and make a difference when it matters most!

At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.

The Team

The Regulatory Affairs Manager will join the Regulatory Affairs department at Mundipharma, accountable for global regulatory strategy and will work closely with all regulatory leads across Marketed Products, providing management and coordination of key regulatory and labelling activity in the global regulatory team.

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

What we offer in return

• Flexible benefits package

• Opportunities for learning & development through our varied programme

• Collaborative, inclusive work environment

Diversity and inclusion

Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn’t just the right thing, but also the smart thing to do. We are on a journey and will seek to move forward together through education and awareness to build a culture that welcomes and celebrates diversity and uniqueness. We will create a workplace environment where everyone can, every day, bring their authentic selves and is treated with dignity and respect.

About Mundipharma

Mundipharma is a global healthcare company focussing on customers across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.

Mundipharma is dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease as well as other severe and debilitating disease areas. Their guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything they do. For more information visit www.mundipharma.com.

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Additional Job Description:

Primary Location:

Job Posting Date:2025-03-03

Job Type:Permanent