Remote Global Regulatory Affairs Leader

MMS Holdings Inc; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

MMS Holdings Inc. is seeking a senior Regulatory Strategy professional to join our data-focused CRO. You will lead regulatory submissions, provide strategic guidance on international and US filings, and coordinate across multiple regions with cross-functional teams.

The role requires 5+ years in regulatory strategy, with strong knowledge of ICH guidelines and exception handling for expedited programs. This remote US-based position offers opportunities to influence product submissions and ensure

Qualifications

• Minimum 5 years of experience in Regulatory Strategy or similar field.
• Proficiency with MS Office applications.
• Knowledge of ICH guidelines and regional regulatory requirements.
• Experience with regulatory submissions and project oversight.
• Familiarity with ISO 9001/27001 and 21 CFR Part 11 is preferred.

Responsibilities

• Lead regulatory submissions and coordinate responses across regions.
• Provide strategic input on submission planning and regulatory strategy.
• Oversee creation and review of regulatory documents and briefing packages.
• Coordinate with CROs, Authorized Agents, and vendors for global submissions.
• Advise on harmonization of US and international submissions.

Skills

Regulatory knowledge

Regulatory tracking

Regulatory writing

eCTD knowledge

Orphan drug knowledge

Regulatory submissions leadership

Annual reports

Submission strategy

Project management

Tools

MS Office

Adobe Acrobat

SharePoint

eCTD viewer

Job description

MMS Holdings Inc. is seeking a senior Regulatory Strategy professional to join our data-focused CRO. You will lead regulatory submissions, provide strategic guidance on international and US filings, and coordinate across multiple regions with cross-functional teams.

The role requires 5+ years in regulatory strategy, with strong knowledge of ICH guidelines and exception handling for expedited programs. This remote US-based position offers opportunities to influence product submissions and ensure