Key Duties and Responsibilities
* 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 company's 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 or 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 AbbVie's policies and procedures.
* Proactively participate in AbbVie's WHS programs, adhere to policies and promote a safe work environment at all times.
* Adhere to AbbVie's codes of conduct and compliance processes, including timely training and maintaining ethics and integrity.
* Perform other ad hoc duties such as administrative duties, as requested.
Qualifications
* Bachelor's 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, 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, and ISO standards (as appropriate).
* Excellent oral and written communication skills.
* Good proficiency in Microsoft Office (Word, Excel, PowerPoint).
* Proficiency in using regulatory databases, document management systems, and other relevant software tools.
* Willingness to learn, adaptability 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 Australia's 'Right to Disconnect' legislation, we recognize 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.
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.
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