Overview
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The Sr Associate, Manufacturing Regulatory Affairs is responsible for supporting regulatory activities within continuous improvement and compliance projects related to products, manufacturing, and analytical processes. The role ensures that all changes are assessed, documented, and managed in compliance with applicable regulatory requirements.
Job Description
Role Purpose
The Sr Associate, Manufacturing Regulatory Affairs is responsible for supporting regulatory activities within continuous improvement and compliance projects related to products, manufacturing, and analytical processes. The role ensures that all changes are assessed, documented, and managed in compliance with applicable regulatory requirements.
Key Responsibilities
Assess regulatory impact of changes related to manufacturing sites, processes, and products
Plan and support activities associated with CMC (Chemistry, Manufacturing & Controls) variations and manufacturing site changes
Coordinate the collection, review, and organization of GMP documentation required for regulatory submissions
Draft and review documentation supporting CMC variations and manufacturing changes
Prepare product-specific regulatory declarations and contribute to Product Quality Reviews (PQRs)
Collaborate cross-functionally with Quality, Manufacturing, and other relevant departments to ensure alignment on regulatory strategies and timelines
Support continuous improvement initiatives to ensure ongoing compliance with regulatory standards
Qualifications
Education
Degree in Pharmaceutical Chemistry and Technology (CTF), Chemistry, or Industrial Chemistry
A Master's degree in Regulatory Affairs is considered a strong asset
Experience xrdztoy
1–2 years of experience in Regulatory Affairs within pharmaceutical companies, preferably in an international environment
Skills & Competencies
Fluent in English (written and spoken)
Good proficiency with standard IT tools and basic statistical analysis
Strong attention to detail and quality-oriented mindset
Proactive, results-driven approach with the ability to manage assigned responsibilities independently
Excellent communication and interpersonal skills
Ability to work effectively in cross-functional teams