Regulatory Submissions Lead - Hybrid/Glasgow

The Opportunity Hub UK Ltd; Glasgow; Hybrid; GBP 45,000 - 66,000; Full time

Benefits offered by this job

Equity in the business

Hybrid working from Glasgow

Learning and development budget

Flat structure with regulatory input

Job summary

The Opportunity Hub UK Ltd in Glasgow is seeking a Regulatory Submissions Manager to lead regulatory filings and keep submission timelines on track. You will review technical, clinical and quality documentation, build robust trackers, and advise cross-functional teams on regulatory requirements to ensure regulator acceptance on first submission.

This startup roles you as the regulatory function, requiring attention to detail, independence, and strong written communication.

Responsibilities

• Prepare and submit regulatory filings across UK and international markets.
• Manage submission timelines directly with regulators, chasing nothing, missing nothing.
• Review technical, clinical and quality documentation before it goes anywhere near a regulator's desk.
• Build and maintain submission trackers so the whole team knows exactly where every filing stands.
• Advise product and clinical teams on regulatory requirements before decisions get locked in.
• Keep pace with changing healthcare regulation across the markets this company operates in.

Skills

Regulatory submissions

MHRA familiarity

Attention to detail

Self‑starter

Regulatory writing

Deadline management

Job description

The Opportunity Hub UK Ltd in Glasgow is seeking a Regulatory Submissions Manager to lead regulatory filings and keep submission timelines on track. You will review technical, clinical and quality documentation, build robust trackers, and advise cross-functional teams on regulatory requirements to ensure regulator acceptance on first submission.

This startup roles you as the regulatory function, requiring attention to detail, independence, and strong written communication.