Talent Acquisition Specialist
Creatio
Regulatory Associate / Senior Associate
Clinigen
full-time
Posted on:
Origin: • 🇦🇺 Australia
Visit company websiteJob Level
Senior
About the role
- Clinigen, a rapidly growing global specialty pharmaceutical services business, is seeking a detail-oriented and motivated Regulatory Associate to join our dynamic team.
- Assist in the preparation and submission of regulatory documents
- Maintain up-to-date records
- Provide support for regulatory inquiries
- Work closely with the Regulatory Affairs team and other departments to facilitate timely delivery of projects
- Ensure all regulatory submissions are accurate and complete
- Grow career in regulatory affairs and contribute to the success of products
Requirements
- Bachelor's degree in Life Sciences, Pharmaceutical Sciences, or a related field
- 4+ years of experience in regulatory affairs or a related field within the pharmaceutical or healthcare industry
- Demonstrated experience in a regulatory role servicing Australia and New Zealand.
- Knowledge of TGA and Medsafe, other APAC regulatory knowledge is desirable.
- eCTD publishing experience is desirable
- Strong attention to detail and ability to manage multiple tasks effectively
- Excellent written and verbal communication skills
- Proficient in Microsoft Office Suite and ability to learn new software efficiently
- Team player with a collaborative approach and strong interpersonal skills
- Ability to work in a fast-paced environment and adapt to changing priorities
