Regulatory Affairs Associate

🌍 Location: London, hybrd (3 days a week in office)

💷 Salary: £37-55K, depending on experience

🕝Employment Type: Full-Time

🏢 Experience Level: 1-2 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 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, as part of the Tithonia Group, 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—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 Simple Pharma is a place where innovation thrives, and excellence is the norm.

Requirements

The role 👩👨

We’re looking for a motivated and detail-oriented Regulatory Affairs Associate who wishes to gain valuable hands-on experience across a variety of topics. You will join our current Regulatory team and assist with regulatory lifecycle activities for specific products/customers on a global scale. 

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 ⚙

1. Regulatory Affairs 

• Assist the regulatory product owner for all assigned products, which entails:  

• Prepare documentation and supporting materials to be submitted to regulatory agencies, including variations and renewal applications for medicinal products, with minimal supervision 

• Maintaining the product information and associated artworks, and working closely with the supply teams to optimise any changes 

• 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. 

• Clearly communicating and building relationships with relevant health authorities.  

2. Product acquisitions and transfers   

• Assist the Regulatory lead on integration project teams to streamline the marketing authorisation transfer process and associated artwork changes. 

• Filing marketing authorisation transfers on behalf of clients, ensuring high quality and completeness of submissions 

• Support with project management as representative of the Regulatory function and facilitating client regulatory reporting.   

  3. Infrastructure Creation & Improvement 

• Contribute to the development of the functional operating model, improving the regulatory element of the Simple Pharma service offering 

• Contribute to the development and enhancement of internal regulatory processes and workflows.  

• Support efforts to standardise templates, procedures, and documentation practices within the Regulatory Affairs department. 

• Identify gaps in our delivery model and onboard new support agencies where needed to deliver the company goals. 

Who You Are and What You Bring

Required Skills and Qualifications:

• Regulatory Lifecycle Management Experience – You have hands-on experience supporting regulatory activities such as variations, renewals, and maintaining marketing authorisations across multiple markets.
• Artwork Experience – You’ve worked with product information updates and artwork changes, and understand how to collaborate across functions to ensure compliance and timely updates.
• Exceptional Attention to Detail – You are meticulous in your work, with strong documentation skills and an ability to spot inconsistencies in data or submissions before they become issues.
• Business Acumen – You understand the bigger picture—how your regulatory work supports commercial goals, product launches, and operational success. You make decisions with both compliance and impact in mind.
• Stakeholder Engagement – Ability to collaborate with non-technical teams, understand their needs, and communicate insights effectively.
• Project Management – Strong organisational skills with experience managing timelines, coordinating multiple workstreams, and delivering results in a structured, outcome-focused way.
• Degree in a Relevant Field – or equivalent experience.

Preferred Skills and Qualifications:

• Experience in MAT - Involvement in managing MAT procedures is highly advantageous.
• Variation Filing - Hands-on experience preparing and submitting variation applications.
• HA Engagement - Experience liaising with regulatory agencies, either directly or via local agents. Comfortable addressing questions or deficiency letters in a professional, timely manner.

What we offer you

💰 Competitive salary, £37-55k, based on experience, ensuring you're rewarded fairly.
💳 Employee Growth Shares. From day one, you'll receive growth shares, making you a true partner in Simple Pharma's success.

❤️ Comprehensive Private Medical and Dental Insurance: We've got you covered with top-tier health benefits.
🔋 Learning & Development: Enjoy an annual allowance for professional growth.
🏖 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.

🐶 Dog-Friendly Office: You'll find a pup or 2 around our dog-friendly office.

🚲 Cycle to Work Scheme
🍿 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.

The Tithonia Group is a meritocracy - we hire based on people's skills, experiences, and potential to contribute to our success.