Regulatory Affairs Manager
💷 Salary: £65-75k, depending on experience
🕝Employment Type: Full-Time
🏢 Experience Level: 6-8 years
About Simple Pharma
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 to 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 diverse and combined team has more than 30 people across 7 countries, speaking more than 10 languages.We are EBITDA profitable, growing, and are participating in a market that is ripe for new thinking.
At Simple Pharma, our core values— Knowledge and transparency, Agency, First Principle Thinking & Humility—guie 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 Simple Pharma is a place where innovation thrives, and excellence is the norm.
Requirements
The Role
We’re looking for a motivated and creative Manager, Regulatory Affairs to lead the lifecycle management of several products in our portfolio. You'll be working closely with a growing team, 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 for relevant products
- 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
- Support the launch of assigned products in new countries
- Prepare dossiers for price and reimbursement submissions
- Line management of team member(s) and oversight of their professional development
- Contribute to the development of the functional operating model for Regulatory Affairs.
- Identify gaps in our delivery model and onboard new support agencies where needed to deliver the company goals.
- Required Skills and Qualifications:
- 6-8 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
What we offer you
💰 Competitive salary £60-75k based on experience, ensuring you're rewarded fairly.
💳 Employee Stock Option. From day one, you’ll receive stock options, making you a true partner in Simple Pharma’s success.
❤️ Comprehensive Private Medical Insurance: We've got you covered with top-tier health benefits.🔋 Learning & Development: Enjoy an annual allowance for professional growth, plus 2 days of paid study leave to support your development.
🏖 25 days of holidays a year (plus bank holidays)and an option to buy 5 days per year.
🌴 Work from anywhere: Flexibility to work from abroad for the entire month of August.🌎 August Holiday Perk: Use 7 holiday days and get an additional 3 days free.
☀️Summer Hours: Enjoy 2pm Friday finishes during July and August.
🍿 Team Activities: We believe in the power of team bonding and regularly organise company-wide events and overseas company off-sites.
🐶 Dog-Friendly Office: You'll find a pup or 2 around our dog-friendly office
🚲 Cycle to Work Scheme
⚡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.