AddressProclinical is partnered with a leading Australian pharmaceutical company known for developing, manufacturing, and distributing specialized pharmaceutical products globally. The company focuses on providing treatments for critical care, oncology, and other areas where there is a significant unmet medical need. Candidates will experience a company with an outstanding and collaborative culture.
The Role
The Regulatory Affairs Manager will lead and manage the Regulatory team, overseeing all Regulatory Affairs activities. Your primary responsibilities include the preparation, submission, and maintenance of product dossier registrations and licensing requirements.
Responsibilities
- Provide line management for Senior Regulatory Associates and Regulatory Associates
- Act as the primary company contact for Regulatory authorities such as TGA, Health Canada, MHR, EMA, and FDA for product registrations, registration changes, and Marketing Authorizations
- Review submissions to Regulatory bodies generated by the team
- Prepare and submit applications and dossiers to regulatory authorities as needed
- Coordinate Regulatory Affairs meetings with internal and external stakeholders
- Project management of export submissions and external registrations
Experience Requirements
- Degree in a relevant scientific discipline
- 10 years minimum experience within RA prescription medicines in Australia
- Expertise in technical writing and understanding of local guidelines
- Good understanding of GMP and Chemistry Manufacturing Controls
- Experience with people management and leading a team
This role offers a competitive base with bonus and excellent career development opportunities. If interested please apply directly or email your CV to ********@proclinical.com
