Job Description
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join Us as a Country Approval Specialist - Make an Impact at the Forefront of Innovation
The Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission strategy.
What You'll Do:
• Prepare, review and coordinate local regulatory submissions (HSA, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
• Provide local regulatory strategy advice (HSA &/or EC) to internal clients.
• Develop and implement local submission strategy. Provide technical expertise and coordination oversight for projects in collaboration with relevant internal departments.
• Serve as primary contact for investigators and with the local regulatory authorities (in...
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join Us as a Country Approval Specialist - Make an Impact at the Forefront of Innovation
The Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission strategy.
What You'll Do:
• Prepare, review and coordinate local regulatory submissions (HSA, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
• Provide local regulatory strategy advice (HSA &/or EC) to internal clients.
• Develop and implement local submission strategy. Provide technical expertise and coordination oversight for projects in collaboration with relevant internal departments.
• Serve as primary contact for investigators and with the local regulatory authorities (in...