Consumer Health Cmc Lead

7 days ago

Singapore MUNDIPHARMA MANUFACTURING PTE. LIMITED Full time

Efficient management and delivery of Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for the Consumer Health 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 Consumer Health.

**KEY RESPONSIBILITIES & EXPECTATIONS**
- Responsible for RA CMC for all consumer health including RA CMC Strategy and oversight of delivery of RA CMC service from vendors for Marketed Products.
- Escalation point for RA CMC strategy for consumer health
- Act as initial escalation point for Product/Process related RA CMC queries from within the organisation and from vendors for consumer health.
- Provide and drive the direction of the RA CMC service provided to the Mundipharma companies and partners for consumer health.
- Ensure that RA CMC strategies for Consumer Health 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 consumer health.
- Oversight of RA CMC submission content for consumer health. 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 consumer health RA CMC support for Due Diligence.

**KEY SKILLS**
- Excellent knowledge of RA CMC especially in relation to consumer health.
- 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.

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