Global Regulatory Strategy Lead - Remote UK

MMS Holdings Inc; Greater London; Hybrid; GBP 70,000 - 110,000; Full time

Job summary

MMS Holdings Inc. is seeking a Regulatory Strategy professional to lead and coordinate global submissions and regulatory strategy across regions, with a focus on UK-based remote work.

You will guide strategy for scientific advice, CTAs, MAA, and post-approval activities, ensuring alignment with ICH guidance and regional requirements. The role requires 5+ years in regulatory strategy, strong communication skills, and experience in clinical trials and pharmaceutical development.

Qualifications

• Minimum 5 years of experience in Regulatory Strategy or similar field.
• Expert knowledge of scientific principles and concepts.
• Reputation as emerging leader in field with sustained performance and accomplishment.
• Proficiency with MS Office applications.
• Hands-on experience with clinical trial and pharmaceutical development preferred.
• Good communication skills and willingness to work with others to clearly understand needs and solve problems.
• Familiarity with current 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

• Maintains a strong in-depth knowledge of applicable regulations and ICH guidances as well as regional specific guidelines where they exist.
• Expertisewith MS Office, Adobe Acrobat and SharePoint applications, SAS viewer and eCTD viewer.
• Expertisetracking, reporting of central submission/approval progress, and archiving of all regulatory activity in applicable MMS systems.
• Provides strategic input and technical guidance on regulatory requirements to project teams including oversight for the publishing of regulatory submissions according to ICH guidance and monitors the impact of changing regulations on submission strategies and updates, participating in implementation as applicable; Oversees the completeness of project deliverables by conducting expert reviews prior to release to client.
• Reviews, develops, gives advice on, and/or writes regulatory documents, meeting requests and regulatory responses for Scientific Advice, CTAs, and/or MAA. Serve as the lead strategist for the original marketing application; Oversees the completeness of project deliverables by conducting expert reviews prior to release to client.
• Obtains and maintains Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs).
• Understands the eCTD submission process and how to work with Reg Ops and can answer questions for internal and external stakeholders with regard to the eCTD submission process; Also, understands regional submission variation for marketing applications.
• Knowledge and advisement of expedited approval applications, orphan drug designation, meeting requests, and briefing docs and regulatory responses.
• Acts as POC for regulatory submissions and ex-US Competent Authorities and coordinates across multiple regions for investigative and marketing applications.
• Manages regional label negotiation activities.
• Advises on annual reports and coordinates multiple annual reports; also should have experience with post-approval safety updates.
• Advises on harmonization of US and Global submissions (e.g., VHP, coordinated IND and IMPD writing, management of IB and Protocol amendments across regions, etc.); determines optimal regional submission strategy for marketing applications.
• Coordinates with clinical CROs, local Authorized Agents and third party vendors on global regulatory submissions (overarching PM, managing versioning, coordinating responses to queries and information requests).
• Can optimize a clinical trial submission or marketing application submission strategy based on regional knowledge.
• Oversees the completeness of project deliverables by conducting expert reviews prior to release to client.
• Project Management: <ul><li>Follows processes related to project management as appropriate for medical writing projects (e.g. close-out procedures etc.)</li><li>Manages project risks and timeline.</li><li>Effectively manages multiple projects and delegates as needed to complete projects on time.</li><li>Notifies project manager and line manager of changes to scope and timeline.</li><li>Provides oversight into the creation/maintenance of project plans and input for timelines.</li></ul>
• Participates and guides sponsor in meeting prep specifically for Scientific Advice, pre-submission meetings, marketing applications, and advisory committees.
• Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
• Evaluates and communicate impact of relevant regional regulations, guidance, current regulatory environment and competitor labelling.
• Monitors impact of changing regulations on submission strategies and updates internal and external stakeholders; participates in implementation as applicable.

Skills

Regulatory strategy

ICH guidelines

MS Office

eCTD submission

Project management

Cross-regional coordination

Regulatory submissions

Clinical trial knowledge

Communication skills

ISO 9001 / ISO 27001 familiarity

Tools

eCTD viewer

SAS viewer

SharePoint

Adobe Acrobat

Job description

MMS Holdings Inc. is seeking a Regulatory Strategy professional to lead and coordinate global submissions and regulatory strategy across regions, with a focus on UK-based remote work.

You will guide strategy for scientific advice, CTAs, MAA, and post-approval activities, ensuring alignment with ICH guidance and regional requirements. The role requires 5+ years in regulatory strategy, strong communication skills, and experience in clinical trials and pharmaceutical development.