Regulatory Affairs Associate

AbbVie is seeking a knowledgeable and detail-oriented Regulatory Affairs Associate for a 12 month Max Term Contract opportunity based in Mascot relocating to the Sydney CBD in Q4 2026. The position provides support  for the full spectrum of regulatory activities across Australia and New Zealand including preparing and submitting product registrations variations and renewals maintaining accurate regulatory records across RIM platforms and collaborating with cross-functional teams to provide expert regulatory guidance across product development labeling and marketing activities.

You will bring a strong understanding of Australian and New Zealand regulatory requirements excellent communication and relationship-building skills and the ability to act as a credible liaison with regulatory authorities while thriving in a fast-paced environment and contributing to AbbVies commitment to compliance and commercial success.

KEY DUTIES AND RESPONSIBILTIES

• Monitor and interpret Australian and New Zealand regulatory requirements and guidelines for pharmaceutical medical device and other healthcare products and update internal stakeholders on relevant changes impacting product registrations and compliance.
• Coordinate and compile necessary documentation for regulatory submissions ensuring accuracy completeness and timeliness.
• Submit regulatory submissions including product registrations variations renewals and responses to regulatory requests.
• Collaborate with cross-functional teams to provide regulatory guidance and support for product development labeling and marketing activities.
• Assist in maintaining regulatory records across Regulatory Information Management (RIM) platforms for assigned product portfolio in compliance with local and global procedures to ensure accurate and up-to-date information.
• Prepare and maintain regulatory documentation including prescribing information packaging materials and instructions for use in compliance with applicable regulations.
• Act as a liaison with regulatory authorities fostering positive relationships and representing the companys interests during meetings.
• Participate in internal and external audits to ensure compliance with regulatory requirements and quality management systems.
• Support the commercialisation of products through participation in local brand teams
• Participate in/coordinate special project assignments as determined by the Director of Regulatory Affairs or Regulatory Affairs Manager
• Report any adverse event within 24 hours as per AbbVies policies and procedures.
• Proactively participate in AbbVies WHS programs adhere to policies and promote a safe work environment at all times.
• Adhere to AbbVies codes of conduct and compliance processes including timely training and maintaining ethics and integrity.
• Other ad hoc duties such as administrative duties as requested.

Qualifications :

• Bachelors degree in a scientific discipline or related field. 
• Experience within a similar regulatory role within the healthcare industry
• Experience with TGA (Therapeutic Goods Administration) and Medsafe (Medicines and Medical Devices Safety Authority) regulations GMP (Good Manufacturing Practices) guidelines and processes.
• A commercial focus and a desire to contribute to the overall success of the business
• Ability to work autonomously as well as part of a cross functional team with a proactive and collaborative approach
• Well-organised with an ability to meet deadlines and achieve goals
• Strong detail orientation analytical and problem-solving skills with the ability to assess regulatory risks and propose appropriate solutions.
• Knowledge of quality management systems GMP (Good Manufacturing Practices) and ISO standards (as appropriate).
• Excellent oral and written communication skills
• Good proficiency for Microsoft Office (Word Excel PowerPoint)
• Proficiency in using regulatory databases document management systems and other relevant software tools
• Willing to learn adaptable to change proactive and responsive
• A high level of integrity and ethical conduct ensuring compliance with regulatory and company policies

Flexibility and Availability: In line with Australias Right to Disconnect legislation we recognise and respect employees right to refuse contact outside of their working hours unless such refusal is deemed unreasonable. As we operate in an international matrixed environment there may be occasions where your role requires participation in business meetings outside of standard hours. We value and support flexibility and appreciate your willingness to occasionally accommodate these requests to ensure effective collaboration and communication within our global team.

Additional Information :

WAYS WE WORK

• All For One Abbvie; We weigh all decisions against the common good. We inspire share and create as a team. We solve problems for all rather than serving our immediate team.
• Decide Smart & Sure; We make intelligent decisions to create the best outcomes. We act quickly embrace experimentation and learn what doesnt work and get on to what does.
• Agile & Accountable; We streamline and eliminate unnecessary obstacles. We plan but adapt as we go. We delegate and make tough decisions to ensure focus on results staying keenly aware of the urgency in all we do.
• Clear & Courageous; Open honest candid dialogue is core to our work and how we act with each other. We share information freely and continuously to find solutions. We admit mistakes. We grow stronger by putting the courage of our conviction to the test.
• Make Possibilities Real; We question with endless curiosity. Were never satisfied with good enoughpatients depend on us to deliver more. We challenge ourselves to find creative constructive solutions to turn possibilities into reality.

CODE OF CONDUCT & BUSINESS INTEGRITY STATEMENT

• AbbVie is committed to observing high integrity and ethical standards in all its business dealings with our customers with each other business partners and suppliers. 
• AbbVie as a responsible corporate citizen will adhere to these standards as well as to local national and international laws. 
• All AbbVie employees are responsible for maintaining the Companys reputation for conduct in accordance with the highest level of business integrity ethics and compliance with the law. 
• Soliciting and/or accepting/attempting/offering bribes or any illegal gratification is therefore cause for immediate dismissal. 
• AbbVie is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time