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CMC Regulatory Affairs Specialist

2 months ago

Stockholm, Stockholm, Sweden QRIOS Full time
About the Role

We are seeking a highly skilled CMC Regulatory Affairs Associate to join our team at QRIOS Life Science. As a key member of our CMC Regulatory Business Development Team, you will be responsible for providing support to Chemistry, Manufacturing and Control (CMC) regulatory contributions required for the management of Product Divestments to 3rd Party Customers.

Key Responsibilities
  • Assist in the preparation of regulatory submissions, compilation of submission documentation, and preparation of regulatory components in line with Customer requirements/timelines.
  • Responsible for upload, retrieval, and maintenance of documents for electronic submissions using the appropriate software and applications.
  • Ensure maintenance and filing of regulatory related documentation and track regulatory commitments, submission requests, and deliverables to facilitate efficient transfer of registered information to the 3rd Party Customer.
  • Train, guide and advise others, develop training and user support materials, e.g. job aids, work instructions, training videos, e-learning.
  • Business administration of systems, e.g. provision of system access, application of security models and managing change.
  • Interact with cross-functional groups and attend team meetings as necessary to support submission development and project coordination.
  • Assist in the preparation of agendas, presentations, and other supporting materials for various meetings.
  • Contribute to the development and improvement of related business processes.
  • Ensure the learning from own projects are shared with other colleagues/within the functions.
Requirements
  • Foundational / Associate degree in Regulatory Sciences, Pharmacy, or Pharmaceutical Sciences.
  • Team working skills.
  • IT Skills.
  • Experience in Regulatory Affairs or Quality Assurance.
About QRIOS Life Science

QRIOS Life Science is a leading provider of consulting services to the pharmaceutical and life science industries. We work with Sweden's leading pharmaceutical and life science companies, offering a range of services including research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, and more. As a consultant with QRIOS, you will have the opportunity to work with well-known brands at renowned companies, developing your skills and gaining valuable experience in a short period of time.

We are proud to have a unique culture that inspires innovation and collaboration. Our employees are empowered to express diverse perspectives and are made to feel valued, energized and rewarded for their ideas and creativity. If you are looking for a world of exciting assignments and new contacts, you will like being a consultant with QRIOS Life Science.