Head of CMC Operations

3 weeks ago


Hatfield, Hertfordshire, United Kingdom Pharmiweb Full time
Position Overview:

As the Senior Director of Chemistry, Manufacturing, and Controls (CMC), you will play a pivotal role in overseeing the CMC components of regulatory submissions for biologics products across all global regions. This is a permanent position that requires a strategic mindset and a commitment to excellence in regulatory affairs.

About the Company:

Pharmiweb is a prominent research-driven pharmaceutical organization, renowned for its extensive portfolio in Oncology, Neurology, and Pain management. Our mission is rooted in a human healthcare philosophy, prioritizing patient welfare in every initiative we undertake.

Your Responsibilities:

In this capacity, you will be accountable for the following key responsibilities:
  • Lead the preparation and finalization of CMC sections for EU IMPD/MAA and equivalent documents worldwide.
  • Supervise teams tasked with content development, coordinate reviews with regulatory experts and senior management, ensuring timely delivery of high-quality submission materials.

Qualifications:
  • Proven experience in managing significant biologics submissions, including multiple IMPD and MAA submissions.
  • In-depth knowledge of biochemistry, particularly in relation to antibody and immune system biological processes.
  • Advanced academic qualifications are preferred.

What We Offer:

Pharmiweb provides a competitive salary along with a comprehensive benefits package, which includes:
  • Flexible hybrid working arrangements.
  • Car or car allowance options.
  • Facilities for electric vehicle charging.
  • Discretionary bonuses.
  • Complimentary onsite parking.
  • Subsidized dining options.
  • Opportunities for professional development.
  • Retail discounts.
  • Well-being and mental health initiatives.
  • A multi-faith prayer space.

Next Steps:

If you are interested in this opportunity, please proceed with your application. We value diverse perspectives and experiences, and we encourage applications from individuals of all backgrounds who possess the necessary skills and experience for this role. We look forward to reviewing your application.

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