Regional Regulatory Lead (m/f/d)
Responsibilities
- Serve as a Regional Regulatory Lead for the assigned product portfolio (Therapeutic area Immunology, Respiratory, Transplant) and countries
- Align all regulatory activities with regional and global strategies, ensuring compliance with local requirements
- Communicate effectively to ensure that dossiers meet regional and local content and format requirements
- Coordinate, compile and track high-quality documentation for submissions, including new license applications and lifecycle activities to enhance connectivity and improve submission and approval timelines. This also involves addressing questions related to regulatory submissions
- Build strong relationships with regional regulatory agencies, utilizing negotiation and influencing skills for positive outcomes
- Collaborate with internal functions e.g., Commercial, Manufacturing, Supply Chain, and Medical Affairs to enhance connectivity
- Stay informed about international legislation and guidelines for biological products and related initiatives e.g., rare diseases, orphan drugs
Profile
- A degree in Life Sciences, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous
- Regulatory experience within the international region, supported by additional pharmaceutical or industry experience
- Understanding of the scientific principles and technical requirements relevant to the development of a pharmaceutical product and understanding of the principles of GMP and GCP
- Proficiency in standard regulatory tools : Veeva, DocNet, Trackwise
Benefits
- A very renowned company
- A highly motivated team and an open way of communication
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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