Biomapas is a functional and full outsourcing solution provider to the global life science industry, with key expertise in Clinical Trials, Regulatory Affairs and Pharmacovigilance. 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.

Biomapas is looking for a CMC Regulatory Affairs Manager to join Regulatory Affairs team in EU countries.

Role responsibilities:

  • Planning, reviewing, and writing (if applicable) the Chemistry, Manufacturing and Control (CMC) of regulatory submissions: IND, IMPD, NDA, BLA, MAA, Briefing books for regulatory meetings, responses to regulatory authorities’ questions, as pertinent to authorization or maintenance of medicinal products;
  • Management, planning and organizing CMC tasks and projects;
  • Participating in current/new projects related discussions and provide strategic, scientific and regulatory input, for CMC regulatory and/or procedural aspects;
  • Management and providing support to the team;
  • Participating and contributing with audits;
  • Contribution to reach of Central Operations budget, oversee, and management of financial activities;
  • Reviewing and approving timesheets and expense reports and guidance the performance of assigned staff;
  • Ensuring compliance with applicable regulatory standards.

Role requirements:

  • Bachelor’s or master’s degree in Health or Life Science field;
  • Fluent written and spoken English;
  • More than 5 years experience in preparation and maintenance of CMC components for regulatory submissions of biological and chemical medicinal products;
  • Work experience in pharmaceutical industry and/or scientific/R&D field in new drug development;
  • Knowledge of EU (CP and national) and US regulations/guidance applicable to registration and approval (IND/CTA/NDA/BLA/MAA) and life-cycle management;
  • Basic knowledge of regulations and guidance including ICH guidelines, GCPs, GMPs, GLPs;
  • Problems solving and decision-making skills;
  • Experience in team management;
  • Analytical skills to understand, analyze, interpret, and present scientific data;
  • Strategic thinking and innovative approach.

In Biomapas, you will find a supportive work environment with a guarantee for professional and personal development, as well as a competitive salary, benefits and many more initiatives that will make your daily office life comfortable.

Please apply to cv@biomapas.com

Thank you for your attention.

Be kindly informed that only selected candidates will be contacted.

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

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