CMC Biologics

Proclinical is seeking a CMC Biologics for a Regulatory Affairs service provider, to be based in Vienna on a contract basis.

Job Responsibilities:

• Perform CMC technical writing and editing assignments related to the preparation of CMC components of regulatory submissions and other technical documents such as protocols, reports and procedures, as well as any other documents determined to be within the scope of the role; and ensure that project time-lines are met
• Updating the CMC sections as per the latest manufacturing/ analytical changes and to prepare submission ready packages as per the submission strategy (e.g. variations grouping)
• Work cooperatively with colleagues in applicable functions or departments (e.g., R&D, Process Development, Manufacturing, Supply Chain, Regulatory Affairs, Validation, Quality Control and Quality Assurance) and external organizations (e.g., CMO) to ensure achievement of company objectives relating to the preparation of CMC regulatory submissions and associated activities
• Develop and maintain knowledge and expertise in CMC with an understanding of phase-related expectations throughout the lifecycle of drug development
• Actively contributes as CMC representative in cross functional settings

Skills and Requirements:

• Bachelor's degree in Chemistry, Chemical Engineering, Pharmacy, or closely related field is required
• Advanced degree in Chemistry, Chemical Engineering, Pharmacy, or closely related field is desirable
• Minimum 10 experience in the Biopharmaceutical Industry, or relevant Regulatory environment (in Biologics).
• Demonstrated experience and Knowledge on CMC requirements for Biological products/ Plasma products/ recombinant products regulatory requirements for post approval changes submissions (variations/ supplements) in the different geographic regions.
• Experience in writing CMC components of regulatory submissions together with knowledge of relevant regulatory agency guidance including ICH, FDA, EMA etc.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Jay Foster on +44 203 752 0309 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.