Regulatory Affairs Manager
Vor 3 Tagen
About the Role:
We are seeking a highly qualified Regulatory Affairs Manager to join our team at Daiichi Sankyo Europe GmbH. As a key member of our regulatory team, you will be responsible for leading and coordinating complex regulatory projects and filings in the field of RACMC.
Key Responsibilities:
- Lead and coordinate regulatory projects and filings in the field of RACMC
- Ensure compliance with all relevant technical and regulatory requirements
- Collaborate with internal and external stakeholders to successfully implement regulatory projects, submissions until approval
- Create and maintain regulatory project plans, schedules, and resources
- Monitor project progress and report to Global RACMC management
- Identify and manage regulatory project risks and issues
- Conduct regular project meetings and provide updates to stakeholders
- Develop and implement process improvements to enhance project efficiency
- Participate or lead assigned non-project tasks and process improvements
- Provide technical guidance and support to team members
Requirements:
- Master Degree in Regulatory Affairs is a plus
- Minimum of 3 years of experience in global regulatory affairs
- Project Management knowledge and certification preferred
- Proven ability to plan, coordinate and lead projects simultaneously on multiple projects
- Experience of working in global environment in interdisciplinary teams
- Excellent written and oral communication skills in English, German as a second language preferred
- Strong working knowledge of Microsoft Office
What We Offer:
- Excellent benefits
- Work-Life Balance
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