Regulatory Affairs Associate

**Company Description**

The Regulatory Affairs Associate ensures compliance with regulatory guidelines and requirements for the development, registration, and maintenance of pharmaceutical, medical device, and other healthcare products in Australia and New Zealand. Working with our Aesthetics business, the associate will work closely with internal departments, regulatory authorities, and external stakeholders to support product registration, submissions, and ongoing regulatory compliance activities.

**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/coordinate special project assignments as determined by the Director of Regulatory Affairs or Regulatory Affairs Manager/Sr 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 internal codes of conduct and compliance processes.
- Other ad hoc duties such as administrative duties, as requested.

**Qualifications**
- Bachelor's degree in a scientific discipline or related field.
- Experience with TGA (Therapeutic Goods Administration) and Medsafe (Medicines and Medical Devices Safety Authority) regulations (GMP-Good Manufacturing Practices), guidelines, and processes.
- Minimum 2 years experience within a similar regulatory role within the healthcare industry. Medical Devices experience desired.
- A commercial focus and a desire to contribute to the overall success of the business
- A high level of integrity and ethical conduct, ensuring compliance with regulatory and company policies
- Ability to work autonomously as well as part of a cross-functional team, with a pro-active and collaborative approach
- Well organized, with an ability to meet deadlines and achieve goals
- Detail-oriented with strong organisational and project management skills.
- Strong 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).
- Ability to work in a high paced environment
- Excellent oral and written communication skills
- Excellent attention to detail and time management
- 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

**Flexibility and Availability**: In line with Australia's '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 doesn't work and get on to what does.

**Agile & Accountable;** We streamline and eliminate unnecessary obstacles.