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CMC Marketed Products Lead

Added on:
18 Nov 2019
Contract type:
Permanent
Reference:
TB/CMC/MK/0001
Base Salary:
80000

Description

Well Established Leader in Pain Management are Seeking to Strengthen the Regulatory Team with the Appointment of a CMC Lead for their Range of Established Brands, Providing 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

ROLE

  • 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.

REQUIRED

  • Excellent knowledge of Regulatory Affairs CMC, Especially in Relation to Established Brands/Marketed Products Portfolio
  • Demonstrable 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, Written, Spoken and Presentation
  • Excellent Collaborative Ability with Strong Focus on Satisfying the Needs of Stakeholders and Customers

REMUNERATION

  • £80K Basic Salary with a Substantial Benefits Package

RESPOND

  • Call Terry Blaney on +44 (0)1580 211221 to Learn More about this Career Opportunity or e-Mail terry@arxconsultancy.com with Your Application, Including Your Current CV