Regulatory Affairs Manager - Cambridge, MA - Cambridge , MA | Biospace
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Regulatory Affairs Manager - Cambridge, MA

Miltenyi Biotec, Inc.

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Location:
Cambridge , MA
Posted Date:
11/14/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biotechnology, Pharmaceutical, Regulatory, Regulatory Affairs,

Job Description

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 role:
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.

Requirements

Your profile:
•   You have a Bachelors in biotechnology or pharmaceutical studies
•   You have five years of proven experience in a regulatory affairs role; or equivalent combination of education and experience
•   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. We offer a competitive salary, commission, car allowance, and excellent benefits package.

We empower great science. For 25 years, Miltenyi Biotec has provided innovative tools, instruments, and solutions that advance biomedical research and cellular therapy. We are 1,500 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 apply, go to: https://recruiting.ultipro.com/MIL1021/JobBoard/f8aa5bf4-ab27-596f-9a7d-4ed2197b270d/OpportunityDetail?opportunityId=09a4193d-4fa7-4acb-a22a-a84c295ecd05