Regulatory Affairs Manager (m/f/d)
Responsibilities
- 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
Profile
- 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
Benefits
- Future career growth opportunities
- World renowned pharmaceutical company
About Hays
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.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
- 1
- 2
- 3
- 4
1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
+41 44 225 50 00© Copyright Hays plc, . Das Wort HAYS, die H-Symbole, „Hays Working for your tomorrow" und „Powering the world of work" sowie damit verbundene Logos und Illustrationen sind eingetragene Markenzeichen der Hays PLC. Die H-Symbole sind Originaldesigns, die in vielen Ländern geschützt sind. Alle Rechte vorbehalten.