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Senior Manager, Regulatory Affairs

Posted 12 days ago

  • London, Greater London
  • Any
  • External
  • Expired - 3 months ago
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Location: London
Salary: £72,000-£105,000, depending on experience
Employment type: Full-time
Experience level: 6-10 years
About the company
Simple Pharma's purpose is to be the best home for proven pharma products.
The pharma industry overspends on pharma operations by €100bn per year, putting the success of their pharma products at risk and creating inefficiencies in the healthcare system.
Simple Pharma is building the first end-to-end distribution and compliance services company for pharma product owners. Our Distribute and Comply services allow intellectual property owners to focus on their products without needing to build or maintain pharma backbone capabilities. We pick up from manufacturers and deliver into wholesalers and pharmacies, taking care of everything else in between to keep products in supply. We hold marketing authorisations and comply with all regulatory requirements to maintain the highest possible standard of quality and patient safety. And we do this across Europe with the aspiration to expand globally.
Founded in 2019, we have scaled our operations to manage close to 100,000 units per month and 60 marketing authorisations across 25 countries. Our combined team has to more than 30 people across 7 countries. We are EBITDA profitable, growing, and are participating in a market that is ripe for new thinking. Our diverse team has a range of top academic and professional experience from institutions such as Oxford, INSEAD, Imperial, UCL, McKinsey, Latham & Watkins, PwC, EY, Johnson & Johnson, Accenture, Entrepreneur First, and others.
The role
We're looking for a motivated and creative Senior Manager, Regulatory Affairs to lead the lifecycle management of several products in our portfolio. You'll be working closely with a growing team of 2-3 other regulatory colleagues, including line management responsibilities, with close collaboration with a wider group of operations colleagues.
This is a highly entrepreneurial role in an exciting, early-stage business where you will be encouraged to contribute ideas and help shape the company's trajectory.
What you will be doing
Regulatory Affairs
Accountable for managing the lifecycle of all assigned products, which entails:
Preparing and reviewing documentation and supporting materials to be submitted to regulatory agencies including variations and renewal applications for medicinal products, with limited or no supervision
Maintaining the product information and associated artworks, and working closely with the supply teams to optimise any changes
Prepare applications for marketing authorisations in new markets (for existing and new products)
Ensure compliance of promotional and non-promotional materials regarding the products and therapeutic area
Manage regulatory change requests in compliance with our company's procedures and Quality Management System
Oversee operational activities to support regulatory compliance
Oversee the coordination of support agencies (e.g., regulatory publishing teams) and in-country regulatory experts.
Communicate with and own relationships with health authorities
Support product transfers
Deliver regulatory due diligence and transfer planning for products that Simple Pharma will manage
Provide regulatory leadership on integration project teams to streamline the marketing authorisation transfer process and associated artwork changes
Market access
Support the launch of assigned products in new countries
Prepare dossiers for price and reimbursement submissions
Thought leadership and company development
Line management of team members and oversight of their professional development
Contribute to the development of the functional operating model, and the digitisation of the Simple Pharma service offering
Identify gaps in our delivery model and onboard new support agencies where needed to deliver the company goals.
Who you are and what you're bringing
6-10 years of relevant professional experience within pharma or adjacent fields
Prior decision making responsibility for regulatory product lifecycle management
Problem-solver with high attention to detail
A can-do, no excuses attitude
Someone who can take ownership of tasks and drive them to completion
Humility and a desire to improve
A love of lean, well-oiled processes and operational efficiency
Motivation to join an early stage, high-growth business
Competitive salary £72,000-105,000 based on experience
Employee stock option award on joining
Private health and dental insurance
Work from anywhere for the month of August
Use 7 get 3 free holiday days in August
2pm Friday finishes in July & August
Regular team events
A high performance, ambitious roster of colleagues
Ample training and investment in the team
The chance for rapid professional and personal development, and a springboard into several career paths
The Simple Pharma Group is a meritocracy - we hire based on people's skills, experiences, and potential to contribute to our success.