Regulatory Affairs Consultant – CMC Biologics
Parexel
full-time
Posted on:
Location Type: Remote
Location: Hungary
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Tech Stack
About the role
- Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports.
- Assess change controls and provide regulatory assessments of quality changes in production and quality control.
- Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.
- Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.
- Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
- Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.
- Identify, escalate, and mitigate risks associated with regulatory procedures and activities.
Requirements
- University-level education, preferably in Life Sciences, or equivalent by experience.
- Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.
- Strong understanding of CMC and post-approval regulatory requirements.
- Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations.
- Knowledge of biological processes.
- Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation.
- Understanding of qualification/validation principles.
- Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.
- Fluent in English (written and spoken).
Benefits
- Flexible work arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory affairsCMCquality controlregulatory documentationvalidation principlesbiological processesproject managementrisk mitigationsubmission strategiestechnical writing
Soft Skills
communicationcollaborationproblem-solvingattention to detailorganizational skills