We offer an exceptional opportunity for a person seeking a new challenge and responsibility in a renowned and innovation-driven organization within the pharmaceutical industry.
Our client is a well-established, international pharmaceutical company with a strong focus on clinical development, medical excellence, and patient safety. To ensure continuity within an active development program, the company is seeking a qualified professional for a maternity leave cover on a fixed-term contract.
This is a temporary position with an initial duration of one year, ideally starting in asap, with the possibility to make an immediate and meaningful contribution to ongoing clinical development activities.
Associate Director – Technical Regulatory Affairs (Maternity Cover, 12 months) (all genders)
* 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
* 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
#J-18808-Ljbffr