Regulatory Affairs Manager (m/f/d)

With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.

• Contribute to defining and executing EUCAN or GEM regulatory strategies to support product development and patient access
• Lead or support submission working groups and manage investigational and life-cycle applications in collaboration with global, regional, and local teams
• Prepare for and participate in meetings with Health Authorities, represent Takeda when needed, and manage follow-up actions
• Stay current with regional regulations and guidance, assess impact on development plans, and contribute to internal policy updates
• Track and fulfill post-marketing commitments, ensuring ongoing regulatory compliance throughout the product life cycle
• Effectively present regulatory strategies, timelines, and risk assessments to leadership and cross-functional teams
• Build strong relationships with LOC Regulatory Leads, global teams, consultants, and business partners to align on access and submission goals
• Support innovative patient access strategies and partner with access functions to ensure regulatory documents meet value and access needs

• Has basic regulatory procedure knowledge with major health authorities in the region
• Analyzes issues with attention to detail and makes reasoned recommendations
• BSc. Advanced scientific related degree preferred; BA accepted based on relevant experience
• Proven experience in drug regulatory affairs, preferably within the EU/GEM region
• Familiarity with advanced therapeutic medical products (Cell and gene therapy) is advantageous
• Strong regulatory expertise, including knowledge of regulations and guidance governing drugs and biologics across all phases of development for Emerging Markets and/or EUCAN, along with experience in leading interactions with Health Authorities

• Future career growth opportunities
• World renowned pharmaceutical company

Ihr Kontakt

Referenznummer
834508/1

Kontakt aufnehmen
Telefon:+41 44 225 50 00
E-Mail: positionen@hays.ch

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