Regulatory Affairs Associate

3 days ago

Sydney, Australia Viatris Full time

3801 Upjohn Australia Pty Ltd.

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 here’s how the Regulatory Affairs Associate role will make an impact:
Key responsibilities for this role include:

- Prepare and submit regulatory maintenance submissions within required timeframes;
- Ensures compliance of marketed products with registered details;
- Respond to TGA’s questions by liaising with overseas affiliates and partners;
- Ensures Viatris database systems are accurate and current;
- Provide regulatory advice to company personnel as required;
- Maintain effective communication with TGA and other key internal and external stakeholders;
- Maintain compliance with relevant regulations and company Standard Operating Procedures

The minimum qualifications for this role are:

- Bachelor’s degree or equivalent in Pharmacy, Science or Chemistry;
- 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;
- Some experience in Regulatory Affairs or similar function is preferred but not essential
- Must be eligible to work in Australia (Australian Citizen or appropriate Visa holder).

Position Title: Regulatory Affairs Officer/Associate

Location: Sydney Head Office, Millers Point, NSW

Employment: Full Time, Permanent

At Viatris, we offer competitive salaries, benefits and an 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.

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