Associate Director – Technical Regulatory Affairs (Maternity Cover, 12 months) (all genders)
Lead global CMC regulatory strategy for a 12-month maternity cover.
We are supporting a leading international pharmaceutical company in recruiting an Associate Director – Technical Regulatory Affairs for a 12-month maternity cover. The role will drive global CMC regulatory strategy and ensure timely execution of regulatory submissions and compliance.
Key Responsibilities
* Lead and execute Technical/CMC Regulatory Affairs strategy for assigned development and registration projects
* Prepare and review regulatory quality documentation (CTD Modules 2 & 3, IMPD, IND)
* Prepare briefing books for Health Authority meetings
* Coordinate with CMC, Development Regulatory Affairs, QPs, CMOs, and regulatory partners
* Lead cross-functional discussions and manage documentation challenges
* Evaluate regulatory impact of product and process changes
* Ensure global regulatory and GMP compliance
* Manage documentation storage and track global submissions
Candidate Profile
* Master’s degree or higher in a scientific discipline
* Minimum 7 years’ experience in Technical/CMC Regulatory Affairs
* Strong knowledge of ICH guidelines, GMP, and global regulatory procedures
* Solid understanding of drug substance/product development and manufacturing
* Excellent communication, leadership, and organizational skills
* Fluent in English; additional European languages are a plus
* Proficient in MS Office and documentation systems
Interested? Please get in touch with us to learn more or to apply. We look forward to connecting with you.
#J-18808-Ljbffr