Marketed Products CMC Lead (Director).

ARA-M4-14

• Location: Cambridge (Home working with some travels to Cambridge when needed)
• Job type: Permanent
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. We are looking for a CMC Director to efficiently manage and deliver the Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for Products across EU and ROW. The person will also be responsible for building and maintaining a strong collaborative partnership with products teams especially with team members from Tech Ops and Quality. They will act as Senior Oversight for RA CMC activities and ensure effective, quality delivery of CMC support from vendors.They will also lead a team of permanent employees (CMC regulatory) and supervise contractors and consultants supporting the CMC regulatory objectives and deliverables. Key Responsibilities
• Responsible for RA CMC for products including RA CMC strategy and oversight of vendor delivery.
• Ensure that RA CMC strategies fully recognise risk, provide mitigations and ensure that these are communicated and acknowledged within the organisation for appropriate product team decision making.
• Escalation point for vendors for RA CMC strategy for products and review of delivery output from vendors to ensure that it is fit for purpose and in line with the strategic direction provided.
• Act as initial escalation point for Product/Process related RA CMC queries from within the organisation and from vendors for marketed products.
• Provision of RA CMC support for Due Diligence.
• Responsible for RA CMC focused agency negotiations and interactions, including scientific advice.
• Lead a team of permanent employees within CMC regulatory. Ensure team members have clear performance and development objectives and deliver assigned RA CMC objectives on their portfolio.
• Provide and drive the direction of the RA CMC service provided to the Mundipharma companies and partners by vendors.
Qualifications
• Scientific based degree
• Proven pharmaceutical experience in regulatory or technical CMC
• CMC technical 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 organisation 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
• 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: GB Cambridge Job Posting Date: 2024-09-06 Job Type: Permanent