Careers

Regulatory Affairs Coordinator (Contract)


SUMMARY
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.

QUALIFICATIONS
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.

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

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

OTHER QUALIFICATIONS
• 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.

 

Questions?

Do you have questions about NorthStar, our products, supply solutions, careers or anything else?

Contact Us Today