AbbVie's Mission
Our Mission
AbbVie is dedicated to discovering and delivering innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.
Job Description
The Senior Regulatory Affairs Associate leads and oversees regulatory affairs activities for pharmaceutical, medical device, and other healthcare products in Australia and New Zealand.
This position requires in-depth knowledge of Australian and New Zealand regulatory guidelines, strong leadership skills, and the ability to collaborate effectively with cross-functional teams and regulatory authorities.
The Senior Regulatory Affairs Associate will play a critical role in ensuring compliance, guiding regulatory strategies, and driving successful product registrations and maintenance.
Key Duties and Responsibilities
* Lead and manage regulatory affairs activities for assigned products, ensuring compliance with Australian and New Zealand regulatory requirements and guidelines.
* Develop and implement regulatory strategies to support product development, registration, and commercialisation plans.
* Coordinate and oversee the compilation of necessary documentation for regulatory submissions, ensuring accuracy, completeness, and adherence to timelines.
* Submit complex regulatory submissions, including new product registrations, variations, renewals, and responses to regulatory requests.
* Collaborate closely with cross-functional teams, including R&D, Quality Assurance, Medical Affairs, Market Access, and Marketing, to provide regulatory guidance and support throughout the product lifecycle.
* Support the commercialisation of products through participation in local brand teams.
* Stay updated on changes in the Australian and New Zealand regulatory landscape and communicate relevant updates to internal stakeholders, including potential impacts on product registrations and compliance.
* Act as a primary liaison with regulatory authorities, maintaining positive relationships and representing the company's interests during meetings.
* Lead regulatory intelligence activities, monitoring emerging regulatory trends, guidelines, and legislation, and provide strategic recommendations to ensure ongoing compliance.
* Provide comment on TGA/Medsafe consultation documents as required.
* Provide training and mentorship to junior regulatory affairs team members, fostering their professional development and enhancing their regulatory knowledge.
* 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.
* Collaborate with above country to align strategies and share best practices, particularly related to multinational product registrations and harmonisation efforts.
* Participate in internal and external audits to ensure compliance with regulatory requirements, quality management systems, and industry standards.
* Represent the regulatory affairs function in cross-functional meetings and provide regulatory input in decision-making processes related to product development, labeling, and marketing activities.
* 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 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.
* Minimum 5 years of experience in regulatory affairs within the pharmaceutical, medical device, or healthcare industry, with a strong focus on Australian regulatory requirements.
* In-depth knowledge of Australian and New Zealand regulatory guidelines, regulations, and processes applicable to pharmaceuticals, medical devices, and related healthcare products.
* A high level of integrity and ethical conduct, ensuring compliance with regulatory and company policies.
* Proven experience in leading and managing regulatory affairs activities, including preparing and submitting complex regulatory submissions.
* Strong understanding of TGA (Therapeutic Goods Administration) and Medsafe (Medicines and Medical Devices Safety Authority) regulations, guidelines, and procedures.
* Excellent leadership and interpersonal skills with the ability to collaborate effectively with cross-functional teams and regulatory authorities.
* Knowledge of quality management systems, GMP (Good Manufacturing Practices), and ISO standards (as appropriate).
* Ability to critically appraise data and work in a high-paced environment.
* Willingness to learn, adaptable to change, proactive and responsive.
* Excellent oral and written communication skills, with the ability to effectively communicate complex regulatory concepts to both technical and non-technical stakeholders and experience with preparing reports.
* Excellent attention to detail, time management, and negotiation skills.
Flexible 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.