Enable and protect the organisation in all compliance and legal matters
Foster a culture of high integrity
Ensure adherence to compliance policies, rules, and regulations
Develop and implement procedures, policies, and programs to mitigate risks
Act as the Legal and Compliance Ambassador throughout the organisation
Provide support and consultancy to the company and the Management Team on compliance issues, legal matters, risk management and currently applicable and developing laws and regulations
Represent Australia and New Zealand in the Global Legal, Compliance & Sustainability organisation
Focus on the development and implementation of an effective regional Compliance Program in Australia and New Zealand within the legal framework and ethical standards of the pharmaceutical industry
Monitor and interpret changes in local and international pharmaceutical regulations and assess their impact on business operations
Provide support and guidance in the interactions between healthcare professionals, organisations, patients, and public servants in line with the Compliance processes, laws, and regulations
Create and administer effective action plans in response to audit findings and Compliance violations
Develop and review the Lundbeck Australia and New Zealand Policies and Procedures
Draft company policies, SOPs, and guidelines
Provide training on Compliance and legal matters
Proactively map and identify compliance and legal risks, and outline and follow through on the risk mitigation plans
Support in coordinating the enterprise risk management process in Australia and New Zealand.
Requirements
A Bachelor’s degree in law, regulatory affairs, pharmacy, or related field
A legal practicing certificate is preferred, but not essential
A minimum of 8+ years of proven experience in Business Ethics, Compliance and Legal (preferably within the pharmaceutical or life science industry)
Proven leadership experience
International experience (global mindset) is a strong preference
Experience in Risk Management and knowledge of industry standards
Good knowledge of legal requirements and procedures in Australia and New Zealand
Strong knowledge of Australian pharmaceutical regulations (TGA, GMP) and international standards (FDA, EMA)
Proven ability to manage complex legal and compliance issues in a dynamic environment
Excellent analytical, communication, and stakeholder management skills
Integrity and professional ethics
Global interest and mindset and ability to collaborate and work in teams
Proactive approach and ability to individually drive results
Fluent English, both written and spoken.
Benefits
Lundbeck offers an inspiring workplace and innovative culture
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