Description
My client is currently looking for a CMC, Regulatory specialist, for a 4 month project in the French part of Switzerland. The are looking for someone with the following skills:Your role: As CMC Regulatory Intelligence Specialist, you will support the Regulatory Intelligence Process, which consists of analyzing, interpreting, communicating and acting on intelligence relative to the CMC regulatory landscape, to drive current or future compliance. The scope of the regulatory intelligence program is global.
The Regulatory Intelligence responsibility will consist to:
* Identify the impact of regulatory intelligence information on products, programs or regulatory practices
* Summarize, analyze and communicate regulatory intelligence and the potential impact
* Coordinate reviews of regulatory intelligence, ensuring alignment on position between all affected functions Another important role will be to prepare regulatory documents (Quality), which form the basis of worldwide submissions such as: applications for variations, line extensions, amendments and renewals of existing authorizations, responses to questions from the authorities under the supervision of the CMC Regulatory Product Responsible.
Who you are:
* You have a Bachelor's degree (or equivalent) required.
* You have 3-5 years' experience in the pharmaceutical industry and ideally in the Biotech, field of expertise.
* You have 3-5 years' experience in regulatory affairs, research and development or quality assurance/compliance. * You have knowledge of global health authorities, regulations, product approval and lifecycle processes for major markets
* You have the ability to critically analyze complex and/or ambiguous information an assess impact on products and process
* You have the ability to effectively communicate and summarize complex issues verbally and in writing
* Ability to work independently and focus on multiple issues / deadlines simultaneously
* Experience working within a global team framework and a multi-cultural environment
* You are fluent in English I look Forward to hearing from you.
If you are interested please contact me under:
Sebasitian Spaniol
Tel.:
Email: s.spaniol'@'realstaffing.com