Regulatory Affairs Associate

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Regulatory Affairs AssociateApply locations Sydney, New South Wales, Australia time type Full time posted on Posted Yesterday job requisition id R5661486 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; the Regulatory Affairs Associate role is key to ensure continuity of supply via life cycle maintenance activities for our existing portfolio and to support the registration of new medicines in Australia. Compliance to local and global regulations is essential in the ever-changing regulatory environment.

Key responsibilities for this role include:

• Deliver regulatory submissions within required timeframes;
• Ensure company databases and systems are accurate and current by drafting, updating, reviewing and verifying entries;
• Ensure our company's change control system is accurate and current by creating, reviewing and/or completing change records as required;
• Maintain compliance with relevant regulations and codes and provide regulatory advice to company personnel as required;
• Maintain compliance and up-to-date training with internal Policies, Standard Operating Procedures, and Work Instructions, and adhere to company values and expectations;
• Complete allocated special projects;
• Collaborate cross-functionally to support submissions and projects where required;
• Support regulatory administrative activities as needed;
• Communicate and endorse safety practices, monitor key safety performance indicators and visibly participate in promoting safety policies and initiatives.

The minimum qualifications and experience for this role are:

• Bachelor's degree or equivalent in Pharmacy, Science or Chemistry.
• At least two years' experience in regulatory affairs ideally with prescription medicines.
• Understanding of local and international regulatory guidelines.
• Capacity to investigate and evaluate a problem to develop 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: Regulatory Affairs Associate

Location: Sydney Head Office, Millers Point, NSW

Employment: Full Time, Fixed Term (9 months)

A t Viatris, we offer competitive salar ies , 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.

Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance.

We believe in healthcare as it should be – empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.

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