We are looking for a Regulatory CMC Specialist for a nice and dynamic team working on innovative products development for a temporary contract until the end of this year (potential for being extended).
Regulatory CMC Specialist - 12 Months contract
Our client is a bio pharmaceutical company with its global headquarter based in Switzerland.
- Prepare and write registration files for products to be submitted in the targeted markets
- Ensure Regulatory Compliance
Ensure that the products sold in those countries meet the local regulatory requirements and support the local registration of these products in a professional, compliant and timely manner, provide advice to the local business and regulatory organisations
- Manage product variations globally
- Deliver answers to competent authorities
- Update CMC modules in relation with manufacturing sites
Life science degree (Pharmacist or Chemical Engineer),
Minimum of 3 to 5 years of experience in CMC Regulatory in Pharmaceutical industry
Experience interfacing with multifunctional and multicultural groups, including international regulatory agencies
Excellent English language skills required. Any other EU language is a plus.
Great opportunity to join a fast growing company.