Fantastic opening with one of the Global Leaders in the pharmaceutical space. This opportunity will offer the right candidate the chance to lead a dynamic team, offering direction across several key areas such as Immunology, Infectious Diseases and Neuroscience. If you have extensive knowledge and experience and are looking for a new challenge, then this could be the perfect opportunity for you.
Responsibilities:
- Serve as a key strategic partner in integrating Global Regulations to achieve results in line with the company's future plans.
- Offering direction in order to maximise potential with ongoing projects and continually managing the life-cycle process in multiple geographical areas.
- Member of the Global Regulatory Organisation
- Conduct interactions with national authorities and international agencies for example MPA, PEI, EMA, FDA and WHO in the scope of product development incl. market authorisation
- Supervision of vendors active in regulatory affairs on behalf of the company
- Produce dossiers and other scientific documents for regulatory purposes, while anticipating changes in the regulatory environment.
Requirements:
- 10+ years of regulatory experience in the Pharmaceutical or Biotech space
- Experience with liaising with multiple regulatory boards
- University degree in natural sciences (medicine, pharmacy, chemistry, biotechnology, biology or equivalent)
- Understanding the complex cross-functional management issues.
