Regulatory Affairs Associate - Compliance

Job Description Summary

We're looking for a proactive and detail-oriented Regulatory Affairs Associate - Compliance to join our team at Sandoz Australia on a full-time basis.
In this role, you will support regulatory labelling and related document compliance activities across the Australia and New Zealand portfolio. You'll work closely with local and global stakeholders to ensure product labelling remains accurate, compliant, and aligned with regulatory requirements throughout the product lifecycle.
As part of the Regulatory Affairs team, you'll contribute to high-impact outcomes by:

Job Description

Major Accountabilities 

• Develop and execute project plans to enable high quality regulatory submissions in line with company priorities and regulatory requirements in collaboration with global and local stakeholders
• Research and interpret labelling requirements, including regulatory guidelines, competitor labels, product data, and market-specific requirements. 

• Manage the development, review, and maintenance of compliant product labelling
• Build strong relationships between Regulatory Affairs, Medical Affairs, Patient Safety and Marketing to support both new product launches and lifecycle management activities by providing regulatory guidance and compliance expertise across a range of cross-functional projects and forums
• Provide regulatory input into and review of Risk Management Plans (RMPs), educational materials, patient support programs, and promotional activities to ensure adherence to regulatory and corporate standards while maintaining the safety profile of in market products. 

• Contribute to the Regulatory Department initiatives for process improvements, implementation of new technologies, compliance tracking for audit and digital readiness
• Develop and maintain Standard Operating Procedures (SOPs) to refine processes and procedures
• Develop and maintain metrics tracking and dashboards for quarterly reports and key performance indicators

• Report technical complaints, adverse events, and special case scenarios relating to Sandoz products within required timelines and in accordance with company procedures. 

 

What You'll Bring to the Role 

• Experience in Regulatory Affairs or a related pharmaceutical role. 

• Knowledge of labelling and regulatory compliance requirements. 

• Strong attention to detail and organisational skills. 

• Excellent communication and stakeholder management abilities. 

• Ability to manage competing priorities and meet deadlines. 
• Customer focus

• Relevant qualifications in Life Sciences, Pharmacy, or a related discipline preferred. 

Commitment to Diversity & Inclusion

Sandoz is committed to building an outstanding, inclusive work environment and diverse teams that are representative of the patients and communities we serve.

Why Sandoz?

Generic and biosimilar medicines are the backbone of the healthcare industry, and Sandoz touches the lives of nearly 500 million patients globally each year. While we are proud of this impact, we are driven to do more. Through investments in development capabilities, state-of-the-art production sites, strategic acquisitions, and partnerships, we are shaping the future of affordable, high-quality medicines.

Our momentum is powered by an open, collaborative culture and a team of talented, ambitious associates. We foster an agile and inclusive environment where diversity is valued, innovation is encouraged, and personal growth is supported.

Locally, we are proud to be certified as a Great Place to Work® for the third consecutive year. In 2023 and 2024, we were recognised as one of the Top 50 Australian Companies on the Great Place to Work for Women list and ranked #2 in Australia's Best Workplaces in Biotechnology & Pharmaceuticals 2024.

The future is ours to shape.

#Sandoz

Skills Desired

Detail-Oriented, Labeling Documentation, Labeling Regulations, Operational Excellence, Regulatory Compliance, Safety