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Senior Director, Regulatory Affairs CMC

  • Location

    Pennsylvania, USA

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    29293_1654078891

  • Published:

    about 1 month ago

  • Consultant:

    Matt Thomas

Job title: Senior Director, Regulatory Affairs CMC - Pennsylvania

A global Pharmaceutical company with an array of biopharmaceutical products are seeking a Senior Director, Regulatory Affairs CMC. You will be accountable for CMC Regulatory activities for Biopharm and development products through initial licence applications and the early lifecycle. This is a leadership role managing a team of 8 direct reports and an indirect team of 30.

Responsibilities:

  • Manage the department accountable for delivering CMC strategy and advice for all development products, ensures timely advice and strategy to project teams to secure regulatory approvals for clinical trial, marketing application, and early lifecycle change approvals worldwide.
  • Provide CMC Regulatory Leadership input to CMC governance boards.
  • Establish and directs appropriate agency communications including End of Phase 2, Pre BLA, Scientific advice and ad-hoc product specific agency dialogue.
  • Ensure risk assessments are conducted and appropriate mitigation and treatment plans are defined for product development, effectively liaising with business partners and customers across CMC Development organisation, Quality, the commercial supply organisation, Global Regulatory Affairs and product teams.
  • Manage budget and resource requirements for a department of approximately 40 people
  • Liaise with Head of Biopharm Mature Products to ensure an integrated regulatory strategy for products as they move towards commercial supply

Requirements:

  • Extensive experience across Biopharm product types (mAbs, therapeutic proteins, ADCs, Cell & Gene Therapy).
  • Excellent understanding and extensive experience of product development and technical regulatory requirements.
  • Extensive expertise of diverse market environments and requirements. Proven ability to assimilate new and emerging requirements and establish optimized approach in global context.
  • Development experience including previous roles within product development, deep expertise and understanding of regulatory agencies worldwide and proven ability to effectively interface and communicate with global regulatory agencies.
  • Proven and effective line management capability

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk