Regulatory Associate

2 weeks ago

Council of the City of Sydney, Australia Clinigen Full time

Overview

Clinigen, a rapidly growing global specialty pharmaceutical services business, is seeking a detail-oriented and motivated Regulatory Associate to join our dynamic team. In this role, you will play a vital part in supporting the regulatory activities across Clinigen’s portfolio, helping ensure that our products meet the highest standards of compliance and regulation.

This is an excellent opportunity for someone looking to grow their career in regulatory affairs and make a significant impact within a globally recognized organization.

Responsibilities

- Assist in the preparation and submission of regulatory documents
- Maintain up-to-date records and provide support for regulatory inquiries
- Work closely with the Regulatory Affairs team and other departments to facilitate timely delivery of projects and ensure regulatory submissions are accurate and complete
- Contribute to ensuring compliance with regulatory requirements across Clinigen’s portfolio

Qualifications

- 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

Benefits

- Competitive remuneration
- Annual performance bonus
- Flexible working arrangements
- Ongoing support for professional development
- Paid parental leave
- Onsite parking

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