Description
We are looking for a
Global Program Regulatory Manager (m/f)
Reference: -en
Start: asap
Duration: 6 MM++
Place: in Basel-City
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Support the team in planning and tracking meetings and deliverables to support regulatory submissions
- Support regulatory Lead in the preparation and submission of global original Clinical Trial Applications (CTA)
- Independently prepare maintenance regulatory submission packages such as substantial amendments, DSURs, investigator brochures, clinical study reports etc.
- Support the coordination of teams in the preparation of health authorities responses to submissions
- Interpret and understand regulatory implication of non-clinical and clinical data
- Provide strategic regulatory input into selected clinical trials documents such as protocols, IBs, DSURs
Your qualifications
- Science based BSc or MSc
- Excellent project management skills with proven ability to manage several projects and competing priorities
- Strong interpersonal, communication, negotiation and problem solving skills
- Fluency in English (written and spoken)
- Profound regulatory experience, including proven experience in planning and compilation of CTAs with special focus on European submissions, including addressing Health Authorities questions
- Experience with small molecules and biologicals and the review/approval process in Asia is an additional asset
- Regulatory operational expertise
- Working in a global/matrix environment or cross-functional teams
Skills:
- Clinical project manager