INT-101152
Associate Director – Technical Regulatory Affairs
Basilea Campagna
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Farmaceutico / Biotecnologie / Chimica
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Full-time temporaneo
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.
We are currently offering a new opportunity as:
Associate Director – Technical Regulatory Affairs (Maternity Cover, 12 months) (all genders)
Associate Director – Technical Regulatory Affairs (Maternity Cover, 12 months) (all genders)
Descrizione della missione
- 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
Profilo richiesto
- 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
Il vostro contatto
- home Flexsis - Bâle
- personFlorian Schuster
- quick_reference_allRiferimento: INT-101152
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