At a Glance
- Tasks: Lead regulatory strategy and ensure compliance for a dynamic pharmaceutical portfolio.
- Company: Androlabs, a pioneering pharmaceutical company focused on men’s health.
- Benefits: Competitive salary, leadership role, and the chance to shape regulatory operations.
- Other info: Collaborate with co-founders and cross-functional teams in a vibrant London office.
- Why this job: Make impactful decisions in a senior role that drives innovation in men's health.
- Qualifications: Extensive regulatory affairs experience and strong leadership skills required.
The predicted salary is between 85000 - 105000 £ per year.
Location: Central London (office-based)
Salary: £85,000-£105,000
Employment Type: Full-time, Permanent
Experience Level: Senior (8-14 years)
Androlabs is a pharmaceutical company focused on men’s health, headquartered in London. The role is the most senior regulatory position in the business and reports to the co-founder in charge of Portfolio.
Responsibilities
- Own every regulatory decision and submission across the portfolio; ensure compliance, strategic relevance, and commercial alignment.
- Build and manage a robust regulatory operation from within, including taking ownership rather than performing only coordination.
- Lead MAH and PV compliance activities (PSMF/QPPV arrangements, safety reporting, post-authorization measures, and RMP commitments).
- Lead variation strategy, classification, and final submission sign-off across the portfolio.
- Coordinate and approve labeling and artwork changes; oversee team execution of the process.
- Triage and manage the regulatory and PV mailbox, set positions, assign owners, and identify compliance trends.
- Build and manage the regulatory budget: forecasting, spend approval, cost control, and leadership reporting.
- Define CMC regulatory strategy across the product 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.
- Lead regulatory strategy for new MA submissions and line extensions, define pathways (centralised, MRP, DCP, national), advise on timeline and risk, and lead or support scientific advice meetings.
- Own dossier planning and compilation: content scope, module responsibilities, authoring resources, and query management through to approval.
- Evaluate line extension opportunities and advise on regulatory feasibility; coordinate with Medical, Clinical, and CMC from inception.
- Provide leadership in quality-related activities and ensure alignment with regulatory expectations.
Who you will work with
Co-founders, the CMC team, Quality team, Regulatory Affairs Associate, external regulatory partners and contractors, and health authorities across EU and UK markets.
Qualifications
Minimum: Senior-level regulatory affairs experience with a demonstrated ability to own regulatory strategy and submissions across a portfolio. Strong leadership, budget management, and cross-functional collaboration skills.
Senior Regulatory Specialist in London employer: PVH (Tommy Hilfiger/Calvin Klein)
Intapp is an exceptional employer, offering a dynamic work environment that fosters innovation and collaboration within the accounting and consulting sectors across EMEA. With a strong commitment to employee growth, Intapp provides ample opportunities for professional development and leadership coaching, ensuring that team members thrive in their careers while contributing to the company's strategic vision. The culture is built on accountability and high performance, making it an ideal place for those looking to make a significant impact in a rapidly evolving industry.
Contact Details:
PVH (Tommy Hilfiger/Calvin Klein) Recruitment Team
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We think you need these skills to ace Senior Regulatory Specialist in London
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