Regulatory Affairs Manager, Global Compliance
1 month ago
Gilead Sciences is a research-based biopharmaceutical company committed to creating innovative medicines for unmet medical needs. Our team in Melbourne, Australia, is seeking a highly skilled Regulatory Affairs professional to join our cross-functional department.
Job DescriptionThis 12-month contract role will report to the Senior Director, Regulatory Affairs, and be responsible for preparing regulatory submissions, interacting with departments outside of Regulatory Affairs, and ensuring product packaging and associated information is updated and maintained in accordance with the product licenses.
Key Responsibilities:- Prepare regulatory submissions for investigational and commercial products in line with ICH requirements and scientific and company policies and procedures.
- Submit marketing authorisation and variations applications, as well as safety reports, amendments, supplements, clinical trial applications, and other submissions as required.
- Provide local regulatory expertise for labelling changes and contribute to preparation of country-specific labelling.
- Collaborate with senior Regulatory Affairs professionals to ensure compliance with global regulatory requirements.
To be successful in this role, you will need:
- 8+ years of experience in Australian Regulatory Affairs, with extensive knowledge of ICH requirements and an understanding of global regulatory requirements.
- A degree in a scientific field is preferred.
- Excellent organisation skills, ability to work on multiple projects with tight timelines, and excellent verbal and written communication skills.
- The ability to perform as a senior member of a team with diverse membership from all functions and levels of the company.
We offer a competitive salary of $120,000 per annum, plus benefits, including:
- A generous superannuation package.
- A comprehensive health insurance plan.
- A flexible work environment that supports work-life balance.
- Professional development opportunities to enhance your skills and career growth.
Gilead Sciences is a leader in the biopharmaceutical industry, dedicated to improving the care of patients living with life-threatening diseases. We are committed to fostering a diverse and inclusive workplace culture, where every employee feels valued, respected, and empowered to contribute their best work.
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