Company Description
AbbVie’s mission is to discover and deliver 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. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
The Opportunity
Leading and overseeing 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 be critical in ensuring compliance, guiding regulatory strategies, and driving successful product registrations and maintenance.
CORE JOB 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
Qualifications
PREFERRED 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.
Skills and Abilities:
- In-depth knowledge of Australian and New Zealand regulatory guidelines, regulations, and processes applicable to pharmaceuticals, medical devices, and related healthcare products.
- 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.
- Strong organisational and project management skills, with the ability to prioritise and manage multiple tasks simultaneously.
- Analytical mindset with the ability to assess regulatory risks, propose appropriate solutions, and make sound decisions.
- Proficiency in using regulatory databases, document management systems, and other relevant software tools.
- Knowledge of quality management systems, GMP (Good Manufacturing Practices), and ISO standards (as appropriate).
- Experience in managing interactions with regulatory authorities.
- Ability to critically appraise data
- Ability to work in a high paced environment
- Confidence to conduct presentations in front of small to medium groups within the company
- Good proficiency for Microsoft Office (Word, Excel, PowerPoint)
- Ability to prioritise and work under pressure
- Willing 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 and time management
- Good negotiation skills
- A high level of integrity and ethical conduct, ensuring compliance with regulatory and company policies.
Additional Information
Let’s create a more inclusive world together
AbbVie is dedicated to fostering an inclusive, flexible, and supportive workplace that values and respects every individual. We strongly believe that diverse perspectives are essential for achieving exceptional outcomes, and we actively encourage applications from individuals of all ages, nationalities, abilities, and cultures. We are committed to providing equal opportunities for all employees and ensuring a fair and inclusive recruitment process. If you have any specific requests or accessibility requirements, please inform us at the time of application (via [email protected]), and we will make the necessary adjustments to accommodate your needs.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
