On behalf of our client, Xbrane, we are now searching for a Head of CMC Regulatory Affairs. Xbrane is a commercial phase Swedish biopharmaceutical company specialized in Biosimilars and long acting injectables. Xbrane has world leading expertise in developing generics for long acting injectable drugs and proprietary high-yield protein expression technology for the development of Biosimilars. Xbrane’s headquarter is located in Stockholm and the company’s in-house research and development facilities are in Sweden and Italy. For more information see www.xbrane.com
By joining Xbrane Biopharma as Head of CMC Regulatory Affairs you will have the opportunity to join an innovative and growing team within the development of Biosimilars. You will have the possibility to be part of building the Regulatory Affairs team and ensuring the access of biologics to an underserved patient population and enabling the global health equality. By joining Xbrane you will be part of a journey to create a Swedish success story in bio-pharmaceutical drug development. This position is based at the Xbranes’s headquarter in Stockholm.
You will be responsible for Xbrane Biopharma’s all CMC activities in all stages of the Biosimilar product development. This includes: To produce and manage the IMPD/IND for all Biosimilar products at various stages of the product life-cycle. To ensure that development timelines and regulatory CMC requirements are fulfilled. To work with process developments teams, providing regulatory intelligence, advice, and strategic input, as appropriate. You will work in a team environment, collaborating with process development experts, CDMOs and Regulatory Affairs consultants.
What You’ll Be Doing:
- Overall responsibility for all CMC activities for Xbrane’s Biosimilar programs.
- Participate in regulatory authority communication.
- Ensuring that all CMC related information is compiled into the IMPD/IND in time.
- Providing CMC strategies for all stages of Biosimilar development.
- Coordinate all CMC aspects of global regulatory submissions.
- Representing the Regulatory Affairs CMC function on assigned cross-functional project teams.
- Keep up to date in the field of Regulatory Affairs.
Who We Are Looking For:
- An University degree in Biology/Microbiology/Biochemistry/Pharmaceutical science with several years of experience within the bio-pharmaceutical industry.
- Strong interpersonal skills and the ability to deal effectively with a variety of business areas including R&D, quality, compliance, technical development, process chemistry, manufacturing, and external partners/collaborators.
- Experience in communication with relevant global regulatory authorities.
- Experience and knowledge in the preparation of regulatory submissions.
- Knowledge and understanding of applicable global regulations for Biologics and/or Biosimilars.
- Experience and knowledge in biologics manufacturing, process development, process validation and analytical development.
- Project management experience.
If this sounds interesting and suitable to you, please contact us today for more information or apply directly by uploading your cv and writing to us.
We look forward to your application!