Remote UK: Global Regulatory Affairs Leader

MMS

Greater London

Remote

GBP 90,000 - 120,000

Full time

29 hours ago
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Job summary

MMS Holdings Ltd. is seeking a Regulatory Strategy professional to guide submissions for the UK and global markets. You will work with cross-functional teams to ensure regulatory compliance and strategic alignment throughout product development and lifecycle management.

Ideal candidates bring extensive experience with ICH guidelines, EMA/MHRA, and eCTD processes, plus strong leadership and communication skills. This remote UK-based role offers collaboration across a global CRO network.

Qualifications

  • 5+ years in Regulatory Strategy or similar field.
  • Excellent knowledge of ISO 9001 and ISO 27001 standards.
  • Familiarity with 21 CFR Part 11, EMA, MHRA, and GCP requirements.
  • Strong communication and problem-solving abilities.
  • Experience with regulatory submissions and timelines.

Responsibilities

  • Develop regulatory strategies for submissions and registrations.
  • Coordinate global/regional submissions with internal teams and regulators.
  • Provide guidance on regulatory requirements to project teams and oversee document quality.
  • Lead or participate in scientific advice meetings and pre-submission activities.
  • Manage timelines and risks across multiple projects.

Skills

Regulatory strategy
Regulatory writing
Project management
Communication
Problem solving

Tools

MS Office
Adobe Acrobat
SharePoint
SAS viewer
eCTD viewer

Job description

MMS Holdings Ltd. is seeking a Regulatory Strategy professional to guide submissions for the UK and global markets. You will work with cross-functional teams to ensure regulatory compliance and strategic alignment throughout product development and lifecycle management.

Ideal candidates bring extensive experience with ICH guidelines, EMA/MHRA, and eCTD processes, plus strong leadership and communication skills. This remote UK-based role offers collaboration across a global CRO network.

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