Description
Good day,I am looking for a CMC Regulatory Intelligence Specialist.
Our Client a global Pharmaceutical Company, based in the French part of Switzerland, is looking for a CMC specialist/Regulatory Intelligence.
Please see the job description below.
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 Task will be to prepare regulatory documents (Quality), 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.
Your profile:
* You have a Bachelor's degree (or equivalent) required. * You have 3-5 year's experience in the pharmaceutical industry and ideally in the Biotech, field of expertise.
* You have 3-5 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 MOST IMPORTANTLY is Regulatory Intelligence.
Due to the law in Switzerland ( non EU ) I prefer to discuss the contractual situation with you on the phone. Please apply only with a valid European Citizenship/ or a valid Swiss Work permit.
If you are interested in this opportunity please forward your CV or for further information, you can contact me on the details below.
Yours sincerely
S.Keel