CMC Technical Regulatory Writer
The candidate will be expected to be key member of the Regulatory Affairs area.
The candidate will be expected to provide quality assurance and regulatory oversight.
Proficiency and capability in managing activities in a fast paced environment is expected.
Assessment criteria:
• At least three years’ experience in Quality Assurance, Regulatory Affairs or CMC groups from a related industry, with a preference from within the biopharmaceutical industry
• Experience in Writing IMPDs as far as CMC information is concerned for Biologics (recombinant proteins, monoclonal antibodies, vaccines,…)
• Experience in writing CMC (technical) parts of regulatory documents (registration files or variations) for EU, US and International for Biologics
• Knowledge of regulatory procedures / systems / guidance
• Knowledge of the EU/US variations policy
• Experience in writing Responses to Questions raised by Regulatory Authorities on CMC matters
• Experience in review of raw data and supporting reports for regulatory purposes.
• Proven initiative and independent thinking to deliver tasks on time, whilst working in a team environment.
• Capable to identify data errors and proper management of them taken into account quality assurance and regulatory aspects.
• Demonstrated strong writing and communication skills.
• Proficiency to work within regulatory guidelines.
• Manages own time to meet agreed short-term targets
• Team player: ability to interact effectively with teams and customers
Other requirements:
• Fluent in English.
• Willing to relocate to Northern Spain
Desarrollado por Web4Bio