Senior Regulatory Affairs Associate

4 weeks ago

Sydney, New South Wales, Australia Viatris Full time
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Alphapharm 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 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:
  • Bachelor's 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 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.Seniority level
  • Seniority levelMid-Senior level
Employment type
  • Employment typeFull-time
Job function
  • Job functionLegal
  • IndustriesPharmaceutical Manufacturing

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