We are currently looking for dynamic and highly-motivated Regulatory Coordinator on a full-time basis to join our growing team in Austin, TX.
Reporting to the Regulatory Affairs Manager, the incumbent will be involved in frequent review of new policies, procedures and changing compliance guidelines of local, federal and global regulatory agencies.
- In collaboration with the Regulatory Affairs Manager, formatting regulatory submissions for electronic submission to regulatory authorities
- Submitting applications and related documents under the supervision of the Regulatory Affairs Manager
- Facilitating responses to queries from the vendor assigned to submit applications to regulatory authorities
- Assisting in the tracking and filing of documents associated with regulatory filings
- Serving as the Regulatory Affairs Manager back-up during absences
- Performing tasks as diverse as document management, coordination of meetings for large regulatory projects, CTMS maintenance, and eTMF maintenance
- Maintaining clinicaltrials.gov website
- Supporting the Regulatory Affairs Manager in project tasks as they arise
- University Degree, B.Sc. or higher in Health Sciences
- Minimum 2-3 years of relevant regulatory experience in Clinical Research
- Strong working knowledge of US, Canadian and international regulatory guidelines
- Excellent organizational and communication skills
- Ability to prioritize projects, coordinate multiple projects simultaneously and work with tight deadlines
- Good business acumen and sense of urgency
- Agility and flexibility
How to Apply
Please submit your CV and cover letter in PDF format to firstname.lastname@example.org. Please indicate the position title in the subject line of your email. We will contact you should we wish to arrange a meeting to discuss this position further.