Regulatory Affairs Specialist
The Regulatory Affairs Specialist plays a crucial role in ensuring compliance with regulatory guidelines and requirements for the development, registration, and maintenance of pharmaceutical, medical device, and other healthcare products.
This position requires strong analytical and problem-solving skills, with the ability to assess regulatory risks and propose appropriate solutions.
The ideal candidate will have experience with Australian and New Zealand regulations, as well as a commercial focus and a desire to contribute to the overall success of the business.
Key Responsibilities:
* Monitor and interpret Australian and New Zealand regulatory requirements and guidelines.
* Coordinate and compile necessary documentation for regulatory submissions.
* Submit regulatory submissions, including product registrations, variations, renewals, and responses to regulatory requests.
* Collaborate with cross-functional teams to provide regulatory guidance and support.
* Maintain regulatory records across regulatory platforms.
* Prepare and maintain regulatory documentation, including prescribing information and packaging materials.
* Liaise with regulatory authorities and foster positive relationships.
* Participate in internal and external audits to ensure compliance with regulatory requirements.
* Support the commercialisation of products through participation in local brand teams.
* Perform special project assignments as determined by the Director of Regulatory Affairs or Regulatory Affairs Manager/Sr Manager.
Requirements:
* Bachelor's degree in a scientific discipline or related field.
* Experience with TGA and Medsafe regulations.
* Minimum 2 years experience within a similar regulatory role within the industry.
* 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 and collaboratively as part of a cross-functional team.
* Well-organised, with an ability to meet deadlines and achieve goals.
* Detail-oriented with strong organisational and project management skills.
* Knowledge of quality management systems, GMP, and ISO standards.
* Excellent oral and written communication skills.
* Good proficiency in Microsoft Office (Word, Excel, PowerPoint).
* Proficiency in using regulatory databases, document management systems, and other relevant software tools.
About Us:
We are a global healthcare leader that discovers, develops, manufactures and markets advanced biopharmaceuticals for severe health conditions.