CMC Regulatory Affairs Director
5 days ago
Mundipharma International is seeking a highly skilled CMC Regulatory Affairs Director to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring the efficient management and delivery of Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for products across EU and ROW.
Key Responsibilities:
- Develop and implement RA CMC strategies for products, ensuring they fully recognize risk and provide mitigations.
- Oversee vendor delivery and ensure that RA CMC strategies are communicated and acknowledged within the organization.
- Act as an escalation point for vendors and review delivery output to ensure it is fit for purpose and in line with the strategic direction provided.
- Provide RA CMC support for Due Diligence and lead a team of permanent employees within CMC regulatory.
- Drive the direction of the RA CMC service provided to Mundipharma companies and partners by vendors.
Requirements:
- 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 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.
About Mundipharma International:
Mundipharma International is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. We are 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.
What We Offer:
- Flexible benefits package.
- Opportunities for learning & development.
- Collaborative, inclusive work environment.
Diversity and Inclusion:
We believe in building an inclusive environment where people can thrive, grow, and achieve their full potential. We prioritize diversity and inclusion, recognizing that it's not only the right thing to do but also the smart thing to do, as we focus on making a positive difference for our customers and their patients.
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Cambridge, Ontario, Canada Mundipharma International Full time{"title": "CMC Director", "content": "Job SummaryWe are seeking a highly skilled CMC Director to lead our Regulatory Affairs team in delivering high-quality products across the EU and ROW. As a key member of our team, you will be responsible for managing and delivering RA CMC outcomes, building strong partnerships with product teams, and ensuring effective...
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