Senior Regulatory Affairs Associate
Senior Regulatory Affairs Associate
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Job Description
At VIATRIS we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access Providing high quality trusted medicines regardless of geography or circumstance;
Leadership Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership Leveraging our collective expertise to connect people to products and services.
Every day we rise to the challenge to make a difference and heres how the Senior Regulatory Affairs Associate role will make an impact:
Key responsibilities for this role include:
- Lead and deliver regulatory submissions within required timeframes
- Maintain compliance with all relevant regulations and guidelines; and provide regulatory advice to junior Associates and company personnel as required
- Maintain effective communication with TGA and other key internal and external stakeholders
- Respond to queries from TGA by liaising with overseas affiliates and partners
- Ensure regulatory systems and databases are accurately maintained and current
- Collaborate cross-functionally to review required information for submissions and support projects where required
The minimum qualifications for this role are:
- Bachelors degree or equivalent in Pharmacy Science or Chemistry
- 3 years experience in Regulatory Affairs
- The capacity to investigate and evaluate a problem and arrive at a number of effective solutions
- Excellent communication skills (written and verbal)
- Ability to multitask and work to deadlines
- Demonstrated ability to work well in a team environment and co-operate with others to achieve goals within specified timeframes
- Must be eligible to work in Australia (Australian Citizen or appropriate Visa holder)
Position Title: Senior Regulatory Affairs Associate
Location: Sydney Head Office Millers Point NSW
Employment: Full Time 12 Month Fixed-Term
At Viatris we offercompetitivesalaries benefitsandan inclusive environment where you can use your experiences perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.
Required Experience:
Senior IC
Employment Type
Full-Time
