Regulatory Affairs Head of RA CMC bei Peopleservices

Regulatory Affairs Head of CMC

Location: Cambridge

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.

Role and Responsibilities

This role leads the RA CMC team, overseeing employees and vendors to deliver regulatory CMC product
strategy and deliverables across EU and ROW markets for the full product portfolio.
Engage with technical stakeholders across the organization including quality, supply chain and technical
operations.

• Responsible for RA CMC deliverables for products including RA CMC product strategy and oversight of vendor delivery.

• Ensure that RA CMC strategies fully recognize risk, provide mitigations and ensure that these are communicated and acknowledged to product teams.

• Serve as the go to contact for internal RA CMC queries from the technical and quality team, including due diligence and regulatory agency interactions, to resolve issues efficiently and support informed decision making

• Ensure all regulatory processes, controlled documents, and knowledge resources are accurate, up to date, and consistently applied, supporting compliance and alignment with broader regulatory objectives

• Ensure the team of employees and vendors delivers high quality regulatory outcomes by setting clear objectives, providing guidance, and monitoring performance to maintain operational efficiency and accountability

What you’ll bring

• 10 years pharmaceutical experience in regulatory or technical CMC

• 2 years regulatory CMC experience

• Excellent knowledge of RA CMC in relation to global initial registrations and lifecycle management.

• Proven ability to drive efficient technical regulatory stewardship of products working in collaboration with internal and external partners.

• Strong organization and problem-solving skills.

• Self-motivated, driven with a positive attitude.

• Excellent communicator and collaborator with strong customer and stakeholder focus.

• Ability to effectively motivate and manage a team to deliver RA CMC objectives

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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