Global Submissions Management Director

4 weeks ago


Hatfield, Hertfordshire, United Kingdom Pharmiweb Full time
Job Summary

The successful candidate will be responsible for overseeing 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.

Key Responsibilities
  • Ensure the timely and compliant submission of regulatory dossiers, including MAAs, variations, renewals, and other filings.
  • Support cross-functional teams to ensure alignment with corporate goals.
  • Maintain a high level of visibility within the organization.
  • Present on various GSM-related topics that broadcast the mission, achievements, current projects, and developments of the GSM organization.
Requirements
  • 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 focus on the EU/UK regions.
  • In-depth knowledge of EU/UK regulatory requirements, eCTD format, and the global submission process.
  • Strong leadership, communication, and problem-solving skills.
  • Proficiency with regulatory submission software and document management systems.
  • Excellent organisational and project management skills.
  • 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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