Regulatory Affairs Associate

Viatris; Sydney; On-site; AUD 80,000 - 90,000; Full time

Benefits offered by this job

Competitive salaries

Inclusive environment

Job summary

A leading global healthcare company is looking for a Regulatory Affairs Associate in Sydney. This role involves ensuring compliance with local regulations, delivering regulatory submissions, and supporting the registration of new medicines. Candidates should have a Bachelor's degree and at least two years in regulatory affairs, with strong communication skills and the ability to work in a team environment.

Qualifications

• At least two years’ experience in regulatory affairs ideally with prescription medicines.
• Understanding of local and international regulatory guidelines.
• Demonstrated ability to work well in a team environment.

Responsibilities

• Deliver regulatory submissions within required timeframes.
• Ensure company databases and systems are accurate and current.
• Maintain compliance with relevant regulations.

Skills

Excellent communication skills (written and verbal)

Capacity to investigate and evaluate problems

Ability to multitask and work to deadlines

Teamwork

Education

Bachelor’s degree in Pharmacy, Science or Chemistry

Job description

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Position Title: Regulatory Affairs Associate

Employment: Full Time, Fixed Term (9 months)

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.

• 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).

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 level

  Associate

Employment type

• Employment type

  Contract

Job function

• Job function

  Science

• Industries

  Pharmaceutical Manufacturing

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