Regulatory Affairs Manager - 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 Manager - Cambridge, MA

Your tasks

As a key member of the Regulatory Affairs team, you will have the exciting opportunity to oversee and manage regulatory affairs activities focusing on antibody production, purification and conjugation. 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 expanding and evolving. Our culture is one that empowers you to embrace new challenges and influence change. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.

We empower great science. For more than 25 years, Miltenyi Biotec has provided innovative tools, instruments, and solutions that advance biomedical research and cellular therapy. We are 1,800 scientists, engineers, physicians, support specialists, marketers, and more – all dedicated to improving scientific understanding and impacting human lives. At our headquarters campus and offices worldwide, fresh ideas become unique products.

Miltenyi Biotec is an EO Employer – M/F/Disability/Veteran

To learn more please contact:

Human Resources,
North America
+1 530 887 5304

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Miltenyi Biotec Inc.
Phone: +1 800 FOR MACS
Fax:+1 877 591 1060
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