Senior Global Program Regulatory Manager (m/f/d)
Responsibilities
- Provides input to global program regulatory strategy, including innovative approaches
- May lead global regulatory affairs (RA) for specific program aspects
- Coordinates regulatory readiness across functions and regions
- Represents RA in cross-functional activities
- Contributes to core data sheet development and maintenance
- Coordinates Health Authority (HA) interactions
- Leads planning and submission of clinical trials
- Implements global registration strategy into regional submissions
- Ensures timely compliance reports submission
- Manages life cycle activities, including portfolio transformation and operational excellence
Profile
- Science based BS or MS. Advanced degree (e.g., MD, PhD, PharmD, regulatory) preferred
- Advanced understanding of pharmaceutical development, clinical trials, analysis and interpretation of scientific data
- Awareness of post-marketing/brand optimization strategies and commercial aspects
- Multiple years involvement in regulatory and pharmaceutical development spanning activities in Phases I-IV in 1 or more major region
- Experience in leading cross-functional teams
- Strong collaboration, communication influencing and problem solving skills
- Organizational awareness (e.g., interrelationship of departments, business priorities)
- Compliance and Quality mindset
- Languages: Fluency in English both written and spoken is requirement as a business language. Additional language is an asset
- Must be located in GMT+1 zone
Benefits
- Very Renowned Pharmaceutical Company
- International Environmen
- Ability to work Fully Remote
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
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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
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