Regulatory Affairs Coordinator (Contract)

The Regulatory Affairs Coordinator will have primary responsibility to assist other Regulatory members with daily regulatory activities, documentation prep, and submission prep. The Regulatory Affairs Coordinator will also assist with any Regulatory based administrative work.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:

1. Provides clerical support needed to obtain regulatory approval for NorthStar’s submissions.
2. Utilizes several different computer programs to maintain and track data.
3. Assist other Regulatory staff as needed for general typing and filing of RA documents.
4. Receives and handles requests from multidisciplinary teams for information on the regulatory status, and information submitted to NorthStar’s applications.
5. Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
6. Support NorthStar’s Quality System and Health & Safety Program by following policies and procedures.

Ability and willingness to travel, both domestically and internationally, up to 5% of the time.

Experience in the pharmaceutical industry, radiopharmaceuticals, and eCTD submission experience is preferred. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

High School Diploma or equivalent required. Bachelor’s Degree in Chemistry, Biology or other related scientific discipline preferred.

Proficient knowledge in Microsoft Office Software programs, including Outlook, Word, and Excel.

• Excellent communication skills, verbal and written
• Ability to work in a team environment, as well as independently
• Ability to handle multiple tasks simultaneously
• Ability to work in a fast-paced environment
• Adaptable to change in the work environment

If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line.



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