Regulatory Affairs Associate

🏢 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.

And we do this across Europe with the aspiration to expand globally.

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.

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.

1. 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.

1. 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.

Requirements

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.

Benefits

What we offer you

💳 Employee Growth Shares. From day one, you'll receive growth shares, making you a true partner in Simple Pharma's success.

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

🗻 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.