Associate Director at Net Talent

4 weeks ago


Hatfield, Hertfordshire, United Kingdom Eisai Full time

Job Summary

The Associate Director of Global Submissions Management oversees the efficient operation of managing regulatory submission processes across the EU, UK, Switzerland, and Growth Market regions.

This position requires strategic leadership, operational expertise, and a strong understanding of global regulatory requirements, especially in the EU, UK, and Switzerland.

The Associate Director will ensure the timely and compliant submission of regulatory dossiers, including MAAs, variations, renewals, and other filings while supporting cross-functional teams to ensure alignment with corporate goals.

Key Responsibilities

  • Regulatory expertise relating to submissions requirements and standards for all ICH regions.
  • Strong pharmaceutical business experience managing staff, contracting, billing, and vendor relations.
  • Demonstrated experience in regulatory submissions management or regulatory operations, with a focus on the EU/UK regions.
  • In-depth knowledge of EU/UK regulatory requirements, eCTD format, and the global submission process with the ability to manage complex projects, collaborate with cross-functional teams, and deliver results in a fast-paced environment.
  • Proficiency with regulatory submission software and document management systems.
  • Excellent organizational and project management skills, with attention to detail and the ability to prioritize multiple tasks.
  • Strategic mindset with the ability to adapt to changing regulatory landscapes and operational demands.

What We Offer

  • Competitive salary and excellent wider benefits package.
  • Hybrid working.
  • Car/Car Allowance.
  • 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.

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