Senior Regulatory Specialist in London

Location: Central London (office-based)

Salary: £85,000–£105,000

Employment Type: Full-time, Permanent

Experience Level: Senior (8–14 years)

Androlabs is the first pharmaceutical company that is entirely dedicated to men. Founded in February 2021 and headquartered in London, Androlabs is a fast-growing and ambitious scaleup company. Our medicines are commercialised in 20+ countries throughout Europe, the UK and Australia.

Our mission is to close the male life expectancy gap by tackling health disparities head-on. We partner with healthcare professionals to raise awareness of men’s health, improve education, and remove barriers to care.

This is the most senior regulatory role in the business. You will report directly to the co-founder in charge of Portfolio and own the complete regulatory lifecycle across our portfolio — from MAH and PV compliance to variation strategy, new product applications, labelling oversight, CMC sign-off, and budget management. You'll lead a small team and a network of external partners, filling expertise gaps by sourcing and directing the right specialists.

What do you need to do to win?

• Own every regulatory decision and submission across the portfolio.
• Keep us compliant, strategically sharp, and commercially relevant.
• Build a well-oiled regulatory machine from the inside.

Who will you work with?

Our Co-founders, the CMC team, Quality team, Regulatory Affairs Associate, external regulatory partners and contractors, and health authorities across EU and UK markets.

What You Will Be Doing?

• Own MAH and PV compliance: PSMF/QPPV arrangements, safety reporting, post-authorisation measures, RMP commitments, SDEAs.
• Lead variation strategy, classification, and final submission sign-off across the portfolio.
• Coordinate and approve labelling and artwork changes; oversee team execution of the process.
• Triage and manage the regulatory and PV mailbox — set positions, assign owners, identify compliance trends.
• Build and manage the regulatory budget: forecasting, spend approval, cost control, transparent leadership reporting.
• Define CMC regulatory strategy across the lifecycle and approve CMC sections for submission readiness.
• Coordinate with the CMC & Innovation Manager to align change implementation plans with regulatory timelines.
• Establish and manage a network of regulatory contractors and firms; onboard, govern, and hold partners accountable for delivery quality.
• Lead regulatory strategy for new MA submissions and line extensions — define the pathway, advise on timeline and risk, lead or support scientific advice meetings.
• Own dossier planning and compilation: content scope, module responsibilities, authoring resources, query management through to approval.
• Evaluate line extension opportunities and advise on regulatory feasibility; coordinate with Medical, Clinical, and CMC from inception.
• Lead, manage, and hold accountable the regulatory team including direct reports, contractors, and external partners.
• Set authoring standards and QC submissions for accuracy, consistency, and regulatory suitability.
• Coach contributors and partners to improve first-time-right quality.

Required Skills and Qualifications:

• 8–14 years in pharmaceutical regulatory affairs, with genuine decision-making responsibility.
• Demonstrable ownership of regulatory lifecycle for a portfolio of products.
• Experience leading or materially contributing to new MA submissions or line extensions through to approval.
• CMC regulatory experience.
• MAH experience.
• PV/PSMF/QPPV awareness.
• Experience managing external regulatory partners, consultants, or an internal team.
• Regulatory budget experience.

Preferred Skills and Qualifications:

• Experience in a small or mid-size pharma environment.
• Familiarity with both EU and UK post-Brexit regulatory frameworks.
• Experience with scientific advice processes.
• An existing network of trusted regulatory contractors and specialist firms.

Benefits:

• Competitive salary based on experience.
• Private Medical Insurance through AXA — from Day 1.
• Learning & Development — £300 annual self-directed learning fund.
• 25 days annual leave (plus bank holidays).
• Summer Getaway Package — take 7 days in August, get 3 extra paid days free.
• August Remote Working — work from anywhere for the whole of August.
• Summer Hours — Early Friday finishes in July and August.
• Dog-Friendly Office.
• Cycle to Work Scheme.
• Discounted gym classes.
• Team Activities.
• High-Performance Team.
• Continuous Investment.
• Career Growth.