Senior-/Manager Regulatory Affairs (m/f) - France
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- Are you eager to work in a dynamic company where new challenges and opportunities are part of your every day life?
- Our company is the leading service provider for the worldwide pharmaceutical industry in regulatory affairs, pharmacovigilance and development consulting.
- We are specialized in effectively designing all aspects of drug and medicinal product registrations – ranging from early development and market entry to product maintenance activities.
- The success of our company resides in the expert knowledge and high motivation of our employees.
- We are looking for motivated, committed candidates who will enjoy working independently within our successful team in a challenging environment.
- So, if your career is much more than just a job for you but rather your passion, then come and join our successful team.
- Prepare or contribute to the writing/review/preparation of regulatory dossiers and documents for medicinal and/or biotech products
- Lead regulatory projects and coordinate project team activities
- Interact with regulatory agencies
- Interact with clients and ensure compliance with the project scopes and budgets
- Contribute to the preparation of proposals
- Ensure compliance with the quality procedures
- Prepare content of presentations for conferences and webinars
- Completed University or engineer degree in pharmacy, life sciences or medicine
- For the senior position a minimum of 5 years and for the manager position a minimum of 3 years of professional experience and technical/project management experience
- Familiar with French and European regulatory requirements for medicinal products
- Distinctly strong service orientation
- Content-related experience in at least one relevant area of Regulatory Affairs
- Fluency in spoken and written English and French
- Ability to manage several projects with limited guidance
- Independent approach to work, flexibility and dedication
- Strong communication skills, social competency, integration capacity
- Strong sense of responsibility, organizational skills and intrinsic motivation