Regulatory Affairs acts as the bridge between pharmaceutical companies and regulatory authorities. At Althera Labs, our RA professionals ensure that products meet stringent European Union regulatory standards while supporting efficient market access.
We currently have multiple openings for professionals experienced in CMC (Chemistry, Manufacturing, and Controls) documentation. This is a strategic role, not just a documentation task, requiring deep technical understanding and regulatory foresight.
📍 Key Responsibilities
As a Regulatory Affairs Specialist focused on the EU market, you will be responsible for:
- Dossier Preparation: Compiling, reviewing, and maintaining high-quality eCTD/CTD dossiers for EU submissions 📂
- CMC Write-ups: Authoring and reviewing Module 3 (CMC) sections in compliance with current EU and ICH guidelines
- Lifecycle Management: Handling variations, renewals, and post-approval changes to ensure continuous compliance 🔄
- Regulatory Strategy: Interpreting guidelines from the European Medicines Agency (EMA) and providing regulatory input during development
🎓 Candidate Profile
We are looking for professionals who understand not only what to submit, but why it matters.
✅ Experience Requirements
- Total Experience: 3–7 years in Regulatory Affairs
- EU Expertise: Proven experience with Centralised, Decentralised (DCP), and Mutual Recognition (MRP) procedures 🇪🇺
- Technical Strength: Mandatory expertise in CMC write-ups and Module 3 documentation
🌟 Preferred Skills
- Strong technical writing and communication skills ✍️
- Ability to manage tight regulatory timelines
- Sharp analytical skills to identify and mitigate submission risks
📈 Why CMC Expertise Matters in EU Submissions
The CMC section (Module 3) is one of the most heavily scrutinized parts of an EU regulatory submission. It defines:
- Drug substance & drug product quality
- Manufacturing processes
- Control strategies and stability data
Even minor inconsistencies in CMC documentation can lead to major delays or MAA rejection. This is why Althera Labs values professionals who bring precision, regulatory intelligence, and technical depth to dossier preparation. 🎯
🏢 Life at Althera Labs
At Althera Labs, we foster a culture built on integrity, collaboration, and continuous learning. Our Regulatory Affairs team is a cornerstone of our success, enabling timely EU market access and ensuring patient safety.
You’ll work alongside experienced professionals, gain exposure to complex EU submissions, and grow in an environment that respects your expertise and supports your long-term career trajectory. 🤝
📩 How to Apply
Ready to elevate your Regulatory Affairs career?
📧 Send your updated CV/Resume to:
debjit.mukherjee@altheralabs.com
Submission Tip:
Please mention:
- Your EU dossier experience
- Notice period
- Current location
This helps streamline the screening process. ⚡
Best Budget earbuds
🌐 Global Regulatory Perspective
While this role focuses on the EU market, alignment with ICH guidelines and awareness of global regulatory trends are essential. Our RA team actively tracks regulatory intelligence, from evolving pharmacovigilance expectations to EU regulatory transitions.
If you enjoy continuous learning and regulatory challenges that sharpen your expertise every day, you’ll fit right in at Althera Labs. 🌍
