Remote UK: Global Regulatory Strategy Lead

MMS Holdings Inc; City of Edinburgh; Remote; GBP 70,000 - 110,000; Full time

Job summary

MMS Holdings Inc is seeking a Regulatory Strategy professional to join our UK-based remote team. You will drive regulatory submissions, provide strategic input on regional requirements and oversee deliverables across multiple regions.

The role requires experience with ICH, GMP/GxP, and global submission processes, with strong stakeholder collaboration and problem-solving skills. Join a globally active CRO that partners with biotech, pharma and medical device clients.

Qualifications

• Minimum of 5 years’ experience in Regulatory Strategy or similar field required.
• Familiarity with ISO 9001 and ISO 27001 standards preferred.
• Familiarity with 21 CFR Part 11, EMA, MHRA, and GCP requirements.
• Basic understanding of CROs and scientific and clinical data/terminology, and the drug development process.

Responsibilities

• Provide strategic input and technical guidance on regulatory requirements to project teams.
• Oversee the completeness of project deliverables by expert reviews prior to client release.
• Lead regulatory submissions and oversee eCTD process across regions.
• Coordinate with regional authorities and CROs for global submissions.
• Advise on harmonization of US and Global submissions and regional strategies.
• Manage project plans, timelines and risks to ensure on-time delivery.

Skills

Regulatory strategy

Project management

Regulatory writing

Stakeholder communication

ISO 9001/27001 knowledge

GxP/ICH familiarity

MS Office/SharePoint knowledge

eCTD knowledge

Tools

MS Office

Adobe Acrobat

SharePoint

SAS viewer

eCTD viewer

Job description

MMS Holdings Inc is seeking a Regulatory Strategy professional to join our UK-based remote team. You will drive regulatory submissions, provide strategic input on regional requirements and oversee deliverables across multiple regions.

The role requires experience with ICH, GMP/GxP, and global submission processes, with strong stakeholder collaboration and problem-solving skills. Join a globally active CRO that partners with biotech, pharma and medical device clients.