Regulatory Affairs Expert in Melbourne
2 weeks ago
Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. Our mission requires collaboration, determination, and a relentless drive to make a difference.
As a knowledgeable professional, you will play a critical role in the discovery and development of life-changing scientific innovations. You will work effectively in a cross-functional team environment and assume a 12-mth contract in the Regulatory Affairs department.
The successful candidate will report to the Senior Director, Regulatory Affairs, and be responsible for preparing regulatory submissions in line with ICH requirements and scientific and company policies and procedures. Key responsibilities include:
- Preparing regulatory submissions for investigational and commercial products for Australia and New Zealand;
- Submissions for marketing authorisation and variations;
- Providing local regulatory expertise for labelling changes and to submission teams on specified projects and topics;
- Contributing to the preparation of country-specific labelling;
- Ensuring product packaging and associated information is updated and maintained in accordance with the product licenses;
- Participating in group meetings and presenting project status updates and strategy approaches to complex programs/projects;
You will also be responsible for ensuring your own self-development and acquisition of required regulatory skills and knowledge. Excellent organization skills, ability to work on multiple projects with tight timelines, and excellent verbal and written communication skills are essential.
We estimate the salary for this position to be around $120,000 per year, based on industry standards and location.
Gilead Sciences values diversity, inclusion, and employee well-being. As an equal opportunity employer, we commit to a diverse workforce and employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information, or other non-job related characteristics.
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