# Senior Regulatory Specialist **Company:** [Androlabs](http://jobs.workable.com/companies/f2qaR4M6ZLWQfrtUS86VRM.md) **Location:** London, United Kingdom **Workplace:** hybrid **Employment type:** Full-time **Department:** Reg Affairs [Apply for this job](http://jobs.workable.com/view/7198e177-7f5a-4e17-aed2-dfbff955ebe2) ## Description 🌍 **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 and ambitious scaleup company. Our medicines are commercialised in 20+ countries throughout 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 can result in excess preventable deaths and illness. Globally, nearly twice as many male deaths are considered preventable compared to females, contributing to the concerning statistic that men live, on average, five years less than women. At Androlabs, our mission is to close the male life expectancy gap by tackling these issues head-on. We partner with healthcare professionals who treat patients daily and lead initiatives to raise awareness of men’s health, improve education, and remove barriers to care. We have already launched the first-ever men’s health pub, developed a leading patient education platform, built a HCP zone with CPD-accredited learning, convened scientific advisory committee meetings with 17 of Europe’s top KOLs, and facilitated publications that have evolved the field of men’s health treatment. By putting patients first and adopting a science-led approach, we are reshaping the traditional pharma model to deliver better outcomes across men’s health We are a diverse team of ~40 people are based across 7 countries, and speak more than 14 languages. We are profitable, growing, and have big ambitions to create a world-leading men's health company that makes a difference in society. At Androlabs, our core values— **Knowledge and Transparency, Agency, First Principle Thinking & Humility** —guide our actions every day. They shape our daily operations and interactions. Whether it’s empowering a colleague with the right information, proactively addressing challenges, or embracing feedback, we live these values every day to ensure that Androlabs is a place where innovation thrives, and excellence is the norm. Androlabs is part of Tithonia Group, an entrepreneurial life sciences company. ## Requirements **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'll lead a small team and a network of external partners, and you'll be the person who fills expertise gaps — including your own — by sourcing and directing the right specialists. This is not a coordination role. There is no larger regulatory function above you. You make the decisions, you approve the submissions, and the buck stops with you. **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 and our Regulatory Affairs Associate, as well as external regulatory partners and 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 genuine decision-making responsibility — not just supporting a senior manager - Demonstrable ownership of regulatory lifecycle for a portfolio of products: variations, renewals, new MAs - Experience leading or materially contributing to new MA submissions or line extensions through to approval, including dossier planning, LoQ management, and health authority engagement - CMC regulatory experience: reviewed and approved CMC sections, managed manufacturing change implications, understands comparability - MAH experience — you know what it means to hold the licence, and you understand the full scope of MAH obligations (manufacturing oversight, PV, serialisation/FMD) - PV/PSMF/QPPV awareness — you understand your obligations as an MAH even if PV is not your specialism - 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 where you've operated without a large team behind you - Familiarity with both EU and UK post-Brexit regulatory frameworks - Experience with scientific advice processes (EMA or national competent authorities) - An existing network of trusted regulatory contractors and specialist firms you can draw on ## Benefits ### What we offer you 💰 **Competitive salary based on experience** ❤️ **Private Medical Insurance** through AXA — from Day 1, including 24/7 virtual GP, physiotherapy, and counselling 🔋 **Learning & Development** — £300 annual self-directed learning fund, plus additional sponsorship available for bigger development goals 🏖 **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** — well-behaved pups welcome 🚲 **Cycle to Work Scheme** 🏋️ **Discounted gym classes** 🍿 **Team Activities**: We believe in the power of team bonding and regularly organise company-wide events and overseas company off-sites. **⚡High-Performance Team**: Join an ambitious and dynamic team that’s passionate about excellence. **⏫ Continuous Investment**: Benefit from ample training opportunities and resources. **🗻 Career Growth**: Experience rapid professional and personal development, opening doors to multiple career paths.