Global Regulatory Affairs Manager — Remote (US)

MMS; United States; À distance; USD 110 000 - 170 000; Plein temps

Résumé du poste

MMS Holdings Inc in the United States is seeking a Regulatory Strategy specialist to lead regulatory submissions across IND, NDA, BLA and MAA contexts. You will coordinate with internal teams and external authorities to ensure compliant, timely submissions and strategic guidance across regions.

You will act as a primary point of contact for US submissions, monitor regulatory changes, prepare briefing documents, and support sponsor meetings with the FDA.

Qualifications

• Minimum of 5 years’ experience in Regulatory Strategy or similar field required.
• Expert knowledge of scientific principles and concepts.
• Reputation as emerging leader in field with sustained performance and accomplishment.
• Proficiency with MS Office applications.
• Familiarity with ISO 9001 and ISO 27001 standards preferred.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.

Responsabilités

• Oversees the completeness of project deliverables by conducting expert reviews prior to release to client.
• Coordinates with clinical CROs, local Authorized Agents and third party vendors on global regulatory submissions.
• Follows processes related to project management as appropriate for medical writing projects.
• Manages project risks and timeline.
• Notifies project manager and line manager of changes to scope and timeline.
• Guides sponsor in meetings with the FDA and advisory committees.

Connaissances

Regulatory strategy

Regulatory submissions

FDA knowledge

eCTD knowledge

Global coordination

Project management

MS Office

SharePoint

eCTD viewer

GxP awareness

Outils

Adobe Acrobat

SharePoint tools

eCTD viewer

Regulatory submission systems

Description du poste

MMS Holdings Inc in the United States is seeking a Regulatory Strategy specialist to lead regulatory submissions across IND, NDA, BLA and MAA contexts. You will coordinate with internal teams and external authorities to ensure compliant, timely submissions and strategic guidance across regions.

You will act as a primary point of contact for US submissions, monitor regulatory changes, prepare briefing documents, and support sponsor meetings with the FDA.