Director Regulatory Affairs Job Description
We are seeking a highly skilled Director of Regulatory Affairs to join our team. This is an exciting opportunity for a professional with a strong background in regulatory affairs, compliance, and quality management.
As the Director of Regulatory Affairs, you will play a critical role in overseeing regulatory compliance, public policy development, and other strategic initiatives that drive the success of our operations in Australia and New Zealand. You will be responsible for developing and executing comprehensive regulatory strategies to support product development, registration, licensing, and approval processes across the ANZ market.
Key Responsibilities:
* Develop and oversee the execution of regulatory strategies to support product development, registration, licensing, and approval processes.
* Evaluate regulatory trends and provide forward-looking guidance to anticipate and address potential challenges.
* Collaborate with senior leadership to align regulatory priorities with business goals.
* Liaise with regulatory authorities, including the TGA, ODC, Ministry of Health (NZ), and New Zealand Medicinal Cannabis Council (NZ).
Qualifications:
Bachelor's degree in Law, Regulatory Affairs, or a related field.
At least 8 years of progressive experience in regulatory affairs, compliance, and quality management, with a minimum of 2-3 years in the pharmaceutical or medicinal cannabis industry.
Proven success in preparing and submitting regulatory documents for product approvals and managing regulatory inspections.
Strong knowledge of regulatory requirements in Australia and New Zealand.
Excellent project management skills and ability to work effectively in a matrix environment.
Strong analytical and problem-solving skills, with the ability to communicate complex ideas effectively.
Strong judgment and decision-making skills, with the ability to adapt quickly to changing circumstances.
Benefits:
* Competitive salary and benefits package.
* Opportunities for career growth and professional development.
* A dynamic and supportive work environment.
* Flexible working arrangements and remote work options.
* Access to cutting-edge technology and resources.
If you have the required skills and experience, we would love to hear from you! Please submit your resume through LinkedIn.
Requirements:
* Submit your resume through LinkedIn.