Senior Manager, Regulatory Affairs

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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.

Requirements

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

Benefits

• 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.