Purpose of role
Efficient management and delivery of Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for the marketed products/Established Brands Portfolio across EU and LAM. Responsible for RA CMC strategy and provision of RA CMC expertise across the assigned portfolio driving optimal RA CMC outcomes.
Act as Senior Oversight for RA CMC activities and ensure effective, quality delivery of CMC support from vendors for marketed products/Established Brands.
- Responsible for RA CMC for all Established Brands including RA CMC Strategy and oversight of delivery of RA CMC service from vendors for Marketed Products.
- Escalation point for RA CMC strategy for Established Brands
- Act as initial escalation point for Product/Process related RA CMC queries from within the organisation and from vendors for Established Brands
Tasks that individual will carry out
- Provide and drive the direction of the RA CMC service provided to the Mundipharma companies and partners for Established Brands.
- Ensure that RA CMC strategies for the Established Brands 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 Established Brands.
- Oversight of RA CMC submission content for Established Brands. 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.
- Provision of Established Brand RA CMC support for Due Diligence.
Key Skills required to do the role
- Excellent knowledge of RA CMC especially in relation to an Established Brands / marketed products portfolio.
- Ability to drive efficient technical regulatory stewardship of a diverse portfolio of products working in collaboration with 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 Strong focus on the meeting the needs of our Stakeholders and Customers.