Associate Director, Global Regulatory Affairs, Precision Medicine
vor 1 Monat
Associate Director, Global Regulatory Affairs, Precision Medicine
Job Summary:We are seeking an experienced Associate Director to lead our Global Regulatory Affairs team in the development of Precision Medicine strategies. The successful candidate will have a strong background in regulatory affairs and experience in leading global teams. The role will involve working closely with cross-functional teams to develop and execute regulatory strategies for Precision Medicine products.
Main Responsibilities:- Lead the development and execution of global regulatory strategies for Precision Medicine products.
- Collaborate with cross-functional teams to ensure regulatory compliance and strategy alignment.
- Develop and maintain relationships with regulatory agencies and partners.
- Provide regulatory guidance and support to teams.
- BS in biological science, healthcare science, or engineering.
- Experience in regulation of companion diagnostics and SaMD within a pharmaceutical company.
- Led global development, submission, and approval activities.
- Experience with clinical trial and licensing requirements for Precision Medicine and Digital Health Products in all major countries.
- Excellent communication skills, ideally in writing and verbally.
- Proven ability to deliver key communication with clarity, impact and passion.
- Commands attention and interest through use of appropriate communication techniques.
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