Regulatory Submissions Manager

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

Join a startup Healthcare company as a Regulatory Submissions Manager in Glasgow.

Healthcare products don't reach patients without a clean regulatory file behind them. This startup is building fast in a sector where one rejected submission can cost months, and it needs someone who treats that process as a craft rather than a box-ticking exercise. The Regulatory Submissions Manager sits right at that pressure point, turning technical and clinical work into submissions regulators actually accept first time.

Here’s what you’ll be doing:

• Preparing and submitting regulatory filings across UK and international markets, keeping every dossier accurate and audit-ready
• Managing submission timelines directly with regulators, chasing nothing, missing nothing
• Reviewing technical, clinical and quality documentation before it goes anywhere near a regulator's desk
• Building and maintaining submission trackers so the whole team knows exactly where every filing stands
• Advising product and clinical teams on regulatory requirements before decisions get locked in, not after
• Keeping pace with changing healthcare regulation across the markets this company operates in

Here are the skills you’ll need:

• Solid experience preparing regulatory submissions within Healthcare, medical devices, or pharma
• Working knowledge of UK MHRA processes, and ideally EU or FDA pathways too
• Sharp attention to detail. A missed reference or inconsistent figure can delay a filing by weeks
• Comfortable working without a large team behind you. This is a startup, so you'll often be the regulatory function
• Clear written communication for building submission documents regulators can actually follow
• Ability to manage several live submissions at once without losing track of deadlines

Key perks and benefits:

• £45,000 to £66,000, depending on experience
• Equity in the business, so the upside is shared
• Hybrid working from Glasgow, with flexible hours built around how you work best
• A genuine learning and development budget, not just a line in the handbook
• A flat structure where your input on regulatory strategy actually shapes the product

Why pursue a career in Healthcare?

Healthcare regulation is only getting more complex, and that means demand for people who can actually navigate it keeps climbing. Glasgow has a growing cluster of healthcare and life sciences activity, making it a smart base for anyone building a long-term regulatory career. Good regulatory people are hard to find. Companies know it, and they pay for it.