Regulatory Affairs CMC Director for EU and ROW Products

1 week ago


Cambridge, Ontario, Canada Mundipharma International Full time
Job Description

We are seeking an experienced CMC Director to oversee the Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for our products across the European Union and Rest of World. This role will involve building and maintaining collaborative relationships with product teams, particularly with members from Tech Ops and Quality.

The successful candidate will act as Senior Oversight for RA CMC activities, ensuring effective delivery of quality CMC support from vendors. They will also lead a team of permanent employees in CMC regulatory and supervise contractors and consultants supporting CMC regulatory objectives.

This role requires strategic thinking to ensure that RA CMC strategies fully recognize risk, provide mitigations, and communicate these within the organization for informed product team decision-making.

The CMC Director will be responsible for RA CMC focused agency negotiations and interactions, including scientific advice. They will lead their team to deliver assigned RA CMC objectives on their portfolio, ensuring team members have clear performance and development objectives.

About You
  • Hold a scientific-based degree
  • Have proven pharmaceutical experience in regulatory or technical CMC
  • Possess CMC technical experience
  • Be able to drive efficient technical regulatory stewardship of products working collaboratively with internal and external partners
Benefits

A competitive salary of approximately £80,000 - £110,000 per annum is available for this role, depending on experience. We also offer a flexible benefits package.

Diversity and Inclusion

Mundipharma International prioritizes creating an inclusive environment where individuals can thrive, grow, and achieve their full potential. If you're interested in hearing about future opportunities at Mundipharma, consider joining our talent community.


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