Beschreibung
Global Regulatory(Global Product Strategy)- Company is a global leader in the plasma protein biotherapeutics to treat rate conditions.
- Contract
- Start: ASAP
- Until: 30th June 2022 + high potential extension
- Location: 99% remote (home office) in Switzerland (or Germany / France). Ideally requested to work from Switzerland
- Very international: Hiring Manager located in USA
Role description:
- Provide expertise to the Global Regulatory Affairs by:
- Owning the documentation of the regulatory components of aggregate safety reports
- Ensuring GRA engagement in aggregate safety report development and maintenance
- Ensuring execution of aggregate safety report submissions to Health Authorities according to strategy
- Resolves and aligns internal GRA functions inputs for aggregate safety reports and questions from health Authorities
Qualification and Experience:
- Regulatory Affairs expert with 5 years of regulatory experience in a global capacity within the pharmaceutical industry
- Experience with life-cycle management of marketed products
- Direct management of health authority interactions including responding to queries and RFIs, marketing authorization applications, aggregate safety reporting (PSURs, DSURs, IND annual reports, 120-day safety reporting, etc.), and post-marketing maintenance
- It would also be helpful to have an experience working in document management systems (e.g. Documentum)
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.