Marketed Products CMC Lead

Marketed Products CMC Lead

Contact length: Permanent

Location: Cambridge, Hybrid - Open to remote working

Department: Regulatory Affairs

Job type: Full Time

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 Marketed Products CMC Lead will join the Regulatory Affairs team at Mundipharma to ensure the efficient delivery of Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for Marketed Products across EU and Rest of The World (RoW).  Responsible for RA CMC strategy and provision of RA CMC expertise and managing and mitigating RA CMC risk throughout the lifecycle of the product portfolio.

Role and Responsibilities

The Marketed Products Lead will be responsible for managing the portfolio of products and leading the regulatory strategy and operational outsource team. Main responsibilities for the role will include:

• Responsible for RA CMC for all Marketed Products including RA CMC Strategy and oversight of delivery of RA CMC service from vendors for Marketed Products.

• Act as initial escalation point for Product/Process related RA CMC queries from within the organisation and from vendors.

• Ensure that RA CMC strategies for the marketed products fully recognise risk, provide mitigations and ensure that these are communicated and acknowledged within the organisation for appropriate commercial decision-making.

• Act as an escalation point for vendors regarding RA CMC strategy and direction for marketed products

• Oversight of RA CMC submission content for marketed products.  Provision of RA CMC strategic direction to vendors.  Review of delivery output from vendors to ensure that it is fit for purpose and in line with the strategic direction provided.
   

What you’ll bring

• Excellent knowledge of Regulatory Affairs CMC especially in relation to the marketed products portfolio.

• Previous technical CMC experience would be ideal

• Ideally Degree qualified in a Science related field

• Ability to lead an external team of CMC regulatory authors to effectively deliver CMC regulatory activities of the portfolio

• Ability to drive efficient technical regulatory stewardship of a diverse portfolio of products working in collaboration wi

• th internal and external partners.

• Strong organisation and problem solving skills.

• Self-motivated, driven with a positive attitude.

• Excellent communication skills.

• Excellent collaborator with strong customer and stakeholder 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, as we focus on making a positive difference for our customers and their patients.

About Mundipharma

Mundipharma is a global healthcare company with a presence 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 and Consumer Healthcare as well as other severe debilitating disease areas. Our guiding principles, centered around Integrity and Patients-Centricity, are at the heart of everything we do. 

Join our talent pool

If you’re not sure this role is right for you but you’re keen to hear about future opportunities at Mundipharma, join our talent community and be the first to hear about new roles.

Additional Job Description:

Primary Location:

Job Posting Date:

Job Type: