Regulatory Affairs Specialist - Cambridge, MA

Do you possess an exceptional attention to detail and the ability to manage multiple projects at a time? Are you passionate about regulatory affairs? If so, come and join us as a…

Regulatory Affairs Specialist - Cambridge, MA

Your tasks

As a key member of the Regulatory Affairs team, you will be responsible to support all company regulatory objectives to ensure that products meet worldwide regulatory requirements on all aspects of product approval and post-marketing compliance. The unique duties of this position will allow you to write, review, coordinate, and compile submissions to appropriate external authorities, while attaining established regulatory goals. Furthermore, you will promote and maintain awareness of regulatory requirements and corporate documentation such as marketing materials, SOPs, material specifications, and stability protocols. Overall, your exceptional ability to drive accuracy and consistency will guarantee the successful completion of the Regulatory Affairs team tasks and goals in a timely manner, which ultimately will drive Miltenyi Biotec’s continued and growing success.

Your profile

  • You have a Bachelors in biotechnology or pharmaceutical studies
  • You have five years of proven experience in a regulatory affairs role
  • You have an in depth knowledge of submission requirements and guidelines including INDs, IDEs, HDEs, NDAs, BLAs, PMAs, CTAs and ITAs
  • You have the ability to correctly interpret and apply international regulations
  • You have a successful track record of managing multiple projects in a timely manner
  • Your communication skills allow you to confidently give presentations, partner with stakeholders and regulatory authorities, and present clear performance expectations 

Miltenyi Biotec is a company that is transforming and progressing. Our culture is one of bold scientific innovation. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.

At Miltenyi Biotec Inc., we have developed state of the art manufacturing processes for innovative cellular therapies. We are scientists, engineers, physicians, support specialists, and more – all dedicated to improving scientific understanding and impacting human lives. At our Sunnyvale facility we strive to find solutions to both the technical and conceptual barriers to enable development of cell and gene therapy approaches for the treatment of human disease. 

Miltenyi Biotec, Inc. is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity

To learn more please contact:

Human Resources,
North America
+1 530 887 5304