Director, Regulatory Affairs - Biomedicine

Cambridge, MA
Oct 04, 2019
Required Education
Masters Degree/MBA
Position Type
Full time

Director, Regulatory Affairs - Biomedicine
Cambridge, MA

Your role:
At Miltenyi Biotec, 2,500 employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies. Our multidisciplinary team combines excellence in research with the development of innovative products for the treatment of serious diseases. In the newly created Miltenyi Biomedicine division, we focus on the development and marketing of cell therapeutics.

• You will be responsible for partnering with key functional leaders to devise regulatory strategy and lead regulatory activities for the U.S. and Canada.
• You ensure that all regulatory goals are met and in compliance with all current industry standards.
• You contribute to the development and implementation of pre-clinical, clinical, CMC, and regulatory strategy for projects in all stages of development.
• You will manage the internal regulatory team, third party regulatory service providers, and regulatory advisors/consultants.

Your profile:
• You hold a Master’s degree from a four year university and have a minimum of 8 years of experience in a pharmaceutical and/or Gene and Cell Therapy drug development environment; or equivalent combination of education and experience.
• You have the ability to interpret, communicate, and present regulatory information as it relate to FDA, ICH, Health Canada and WHO recommendations
• You have a proven track record of successful regulatory submissions and have an in depth knowledge of submission requirements and guidelines including BLAs, NDAs, MAAs, CTAs and INDs.

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands and fingers, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a variety of facilities. Each person performing this job must have a home office environment, which is temperature controlled. This job requires the person to be mobile to visit customer sites. Due to the travel requirements, this position may be exposed to natural elements of nature.

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