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Biologics Submission Manager

2 months ago

Hatfield, Hertfordshire, United Kingdom Eisai EMEA Full time

Job Summary

Eisai EMEA is seeking a highly experienced Director, CMC to lead the preparation and submission of regulatory documents for biologics products globally.

Main Responsibilities

  • Manage and oversee the preparation of CMC sections for EU IMPD/MAA and rest of world equivalent documents.
  • Lead teams in preparing content, arrange reviews by regulatory, SME peers, senior management, and ensure on-time delivery of high-quality submission documents.

Requirements

  • Demonstrated experience with preparation of major biologics submissions, multiple IMPD submissions, and MAA submissions.
  • Demonstrated experience with biochemistry, especially antibody and immune system biological processes.
  • Advanced degree preferred.

What We Offer

  • Competitive salary and excellent benefits package.
  • Hybrid working arrangement.
  • Car/Car Allowance (Depending on role).
  • Electric charging points for Electric/Hybrid vehicles.
  • Discretionary Bonus.
  • Free onsite parking.
  • Subsidised onsite restaurant and coffee shop.
  • Learning and development opportunities.
  • Retail discounts.
  • Well-being & mental health awareness programmes.
  • Multi-faith prayer room.

About Us

Eisai EMEA is a leading research-based pharmaceutical organisation with an extensive portfolio across the Oncology, Neurology, and Pain therapy areas. We put the patient first in everything we do, and we are committed to embracing and celebrating our differences, respecting and valuing each other.