Senior Regulatory Specialist

Location: Central London (office-based)

Salary: £85,000–£105,000

Employment Type: Full-time, Permanent

Experience Level: Senior (8–14 years)

What is Androlabs?

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 scaleup with medicines commercialised in 20+ countries across Europe, the UK and Australia.

What is our mission and how do we work?

Gender disparities in health awareness and access to routine check-ups and treatment contribute to preventable deaths. Our mission is to close the male life expectancy gap by tackling these issues, partnering with healthcare professionals to raise awareness, improve education, and remove barriers to care. We aim to reshape the pharma model by putting patients first and adopting a science-led approach to deliver better outcomes in men’s health.

Our core values are Knowledge and Transparency, Agency, First Principle Thinking, and Humility, guiding daily actions and interactions to foster innovation and excellence.

The Role

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 will lead a small team and a network of external partners, filling expertise gaps as needed.

Your Responsibilities

• Own every regulatory decision and submission across the portfolio.
• Maintain compliance, strategic focus, and commercial relevance.
• Build a well-oiled regulatory machine from within.

Who will you work with?

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

What You Will Be Doing

Lifecycle Regulatory Affairs

• 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

CMC and Portfolio Regulatory

• Define CMC regulatory strategy across the lifecycle (comparability, site changes, specifications) 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

New Product Applications and Line Extensions

• Lead regulatory strategy for new MA submissions and line extensions — define the pathway (centralised, MRP, DCP, national), 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

Leadership and Authoring Quality

• 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

Who You Are and What You Bring

Required Skills and Qualifications:

• 8–14 years in pharmaceutical regulatory affairs, with decision-making responsibility
• Ownership of regulatory lifecycle for a portfolio: variations, renewals, new MAs
• Experience leading or contributing to new MA submissions or line extensions to approval, including dossier planning, LoQ management, and health authority engagement
• CMC regulatory experience: reviewed and approved CMC sections, managed manufacturing change implications, understand comparability
• MAH experience with full MAH obligations (manufacturing oversight, PV, serialization/FMD)
• PV/PSMF/QPPV awareness — understand obligations as MAH even if PV is not your specialism
• Experience managing external regulatory partners, consultants, or internal teams
• Regulatory budget experience

Preferred Skills and Qualifications:

• Experience in a small or mid-size pharma environment with a lean team
• Familiarity with EU and UK post-Brexit regulatory frameworks
• Experience with scientific advice processes (EMA or national authorities)
• Existing network of regulatory contractors and specialist firms

What we offer you

Salary information and benefits are described in the original description and include competitive base salary, private medical insurance, learning and development funds, generous annual leave, summer programs, remote working options, and team activities. Benefits are subject to eligibility and company policy.