Join us as a Chemistry, Manufacturing and Control (CMC) Regulatory Affairs Manager

CMC Regulatory Affairs Manager is responsible for managing team, projects, financial activities of Central Operations.

Position is in Europe

Responsibilities:

• Plan and review the Chemistry, Manufacturing and Control (CMC) of regulatory submissions (IND, IMPD, NDA, BLA, MAA etc.)
• Contact person to regulatory authorities
• Manage CMC tasks and projects
• Participate in strategic, scientific CMC regulatory projects planning
• Manage and support the team
• Participate in audits
• Support with Central Operations budget management
• Approve timesheets and expense reports
• Ensure compliance with applicable regulatory standards

Requirements:

• University degree in Health or Life Science field
• Fluent English language
• 5 years experience of CMC components for regulatory submissions preparation
• Experience in pharmaceutical industry (scientific, R&D , new drug development)
• Knowledge of EU and US regulations for registration (IND/CTA/NDA/BLA/MAA) and life-cycle management
• Basic knowledge of ICH guidelines, GCPs, GMPs, GLPs
• Problems solving and decision-making skills
• Experience in team management
• Strategic thinking and innovative approach

Benefits of being a part of our team:

• Professional growth and career opportunities
• Additional benefits (bonus system, additional health insurance and etc.)
• International team
• Remote work
• Supportive work environment

 

Biomapas is a functional and full outsourcing solution provider to the global life science industry, delivering services in Clinical Trials, Regulatory Affairs, Pharmacovigilance and Medical Information. With headquarters in Lithuania and offices in Switzerland, Russia, Georgia, Ukraine, Poland, Kazakhstan and Sweden, Biomapas operations are spread over 5 continents, concentrated in Europe, Russia and former CIS region.

 

Job Category: Regulatory Affairs
Job Type: Full Time
Job Location: Europe

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