Senior Regulatory Affairs Associate

Senior Regulatory Affairs Associate & Senior Regulatory Affairs Specialist

Join a leading global pharmaceutical company as a Senior Regulatory Affairs Specialist, dedicated to advancing treatments for neurological conditions. In this key role, you'll coordinate and oversee regulatory submissions, ensuring compliance with state and federal regulations, as well as internal quality standards. Your work will drive the approval process for innovative products, upholding the highest standards of safety and efficacy. This is a chance to make a significant global impact and contribute to groundbreaking advancements in patient care.

Responsibilities:

• Evaluate scientific content of new registration packages to ensure alignment with regulatory standards before submission to health authorities.

• Oversee and monitor the advancement of marketing applications through the regulatory approval process.

• Engage with regulatory bodies to ensure compliance with product information, storage conditions, shipment requirements, and quality control procedures.

• Oversee and maintain licensing applications for all imported goods.

• Collaborate with government departments such as the Department of Health, TGA, PBB, and PBAC in Australia, and Medsafe and PHARMAC in New Zealand to facilitate product reviews and approvals.

• Work with consultants on major regulatory and health economic submissions.

• Handle inquiries and investigations related to product integrity, storage, and packaging.

• Prepare and update the organisation's Crisis Management plan and internal SOP documentation.

• Contribute to the creation of marketing materials to ensure they adhere to regulatory standards and the Code of Conduct.

• Provide training for new employees on regulatory processes and compliance.

• Manage safety responsibilities, including administrative components of Risk Management Plans (RMPs) and product recall processes.

Skills: