ATLAS MEDICAL SERVICES LTD. STI.
Regulatory Affairs Consultant - CMC author biologics (home or office based)
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Regulatory Affairs Consultant - CMC Author Biologics (Home or Office Based)
Primary Location
United Kingdom, Remote
Additional Locations
- Croatia, Remote; Croatia, Zagreb
- Czech Republic, Prague; Czech Republic, Remote
- Hungary, Budapest; Hungary, Remote
- Lithuania, Remote; Lithuania, Vilnius
- Poland, Remote; Poland, Warsaw
- Romania, Bucharest; Romania, Remote
- Serbia, Belgrade; Serbia, Remote
Job ID
R0000045277
Category
Regulatory / Consulting
Date Posted
08/27/2026
Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
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Success Profile
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
Parexel is seeking experienced CMC (Chemistry, Manufacturing, and Controls) professionals to join us as a Regulatory Affairs Consultant CMC Author to support our client. This position requires expertise in regulatory affairs, CMC authoring for initial submissions and lifecycle management, and other pharmaceutical documentation for biologics. Previous experience working with biologics products is a must.
The role can be home or office based in various European locations.
Role Responsibilities
- Thorough understanding of the drug development process for all phases of pharmaceutical development and applied comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance.
- Thorough understanding of global regulations and ICH guidance pertaining to pharmaceutical development and lifecycle management of NCE/NME products.
- Experience preparing CMC sections of IND/IMPDs, BLA/NDA/MAAs, and supportive clinical amendments and post approval supplements/variations. (ICH Modules 2 and/or 3)
- Write scientific rationales to support regulatory answers, variations, and dossier submissions
- Coordinate CMC activities across multiple projects and manage timelines effectively
- Thorough understanding of change management processes and regulatory requirements.
- Build and assess regulatory strategies for variations and registrations based on affiliate information and EU/US guidelines
- Develop regulatory strategy for medical devices part of combination products
- Update and maintain database with current regulatory information
- Provide ad-hoc CMC consulting support and technical advice
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Required Qualifications & Skills
- University degree in Chemistry, Pharmacy, Chemical Engineering, or related pharmaceutical field
- 10+ years of pharmaceutical industry experience in CMC and regulatory affairs
- Strong expertise in CMC for biologicals– initial submissions and Lifecycle maintenance
- Comprehensive understanding of ICH guidelines and EU/US regulatory guidelines
- Strong problem solving and diplomacy skills
- Ability to manage multiple projects simultaneously and meet deadlines
- Experience with Veeva or similar document management systems
- Fluent English (written and spoken); Additional European languages (French, German, Spanish) are advantageous
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