Regulatory Affairs Jobs at Parexel, UK
Parexel is hiring a Regulatory Affairs Consultant – CMC Biologics to support global post-approval regulatory activities for biological products. The Regulatory Affairs Jobs at Parexel Careers offer the flexibility of home- or office-based work across multiple European locations and provide an opportunity to work on client-dedicated projects within Parexel Consulting. The consultant will leverage scientific and regulatory expertise to guide biopharmaceutical companies through complex CMC regulatory strategies, ensuring compliance and accelerating product lifecycle success.
Job Details:
- Job Title: Regulatory Affairs Consultant – CMC Biologics
- Employment Type: Full-Time
- Work Model: Remote or Office-Based
- Primary Location: United Kingdom (Remote)
- Additional Locations: Multiple European countries including Ireland, Spain, Italy, Poland, Czech Republic, Hungary, Romania, Croatia, Lithuania, Serbia
- Category: Regulatory Affairs / Consulting
- Company: Parexel
- Job Level: Consultant
- Focus Area: Post-Approval CMC – Biologics
About the Company:
Parexel is a leading global biopharmaceutical services organization, dedicated to helping life science companies accelerate the development and delivery of innovative therapies to patients worldwide. Through Parexel Consulting, regulatory experts partner closely with clients to navigate evolving global regulations. Parexel fosters a culture of collaboration, innovation, continuous learning, and flexibility—empowering consultants to grow professionally while working on diverse, high-impact projects.
Educational Requirements for the Regulatory Affairs Consultant Role:
- University-level degree in Life Sciences (preferred)
- Equivalent professional experience in regulatory affairs or pharmaceutical quality/CMC may be considered
Key Responsibilities of the Regulatory Affairs Consultant:
- Develop regulatory submission strategies and plans for post-approval CMC activities, including variations, renewals, annual reports, and market expansions
- Assess change controls and provide regulatory impact assessments for quality and manufacturing changes
- Review quality control and production study reports for regulatory compliance
- Coordinate submission preparation with cross-functional teams including manufacturing, supply chain, QC, QA, and regulatory affairs
- Write and review CMC sections of regulatory submissions and responses to health authority questions
- Manage global submissions within Regulatory Information Management (RIM) systems
- Identify, escalate, and mitigate regulatory risks across projects
- Ensure worldwide submissions remain accurate, compliant, and inspection-ready in this Life Science job.
Skills Required for Regulatory Affairs Consultant Role:
- Strong expertise in CMC and post-approval regulatory requirements
- Hands-on experience with biological products and manufacturing processes
- Proven ability to write and review CMC technical documentation
- Knowledge of quality systems, validation, and qualification principles
- Familiarity with Veeva Vault and regulatory information management systems
- Proficiency in MS Word, Excel, and PowerPoint
- Excellent communication, organizational, and stakeholder management skills
- Detail-oriented, strategic thinker with strong problem-solving ability
- Fluent in English (written and spoken)
Benefits of the Regulatory Affairs Jobs at Parexel Careers:
- Remote-first flexibility with home or office-based options across Europe
- Exposure to diverse global clients, products, and therapeutic areas
- Opportunity to work on high-impact post-approval biologics projects
- Continuous learning through mentorship and challenging consulting assignments
- Collaborative and inclusive work culture at a globally respected CRO
- Career development within Parexel Consulting’s regulatory expertise network
- Strong emphasis on work-life balance and professional growth
