Regulatory Affairs Senior Associate
Great career Opportunity - Full-time, Permanent role Based in Macquarie Park with onsite parking Great team environment: collaborative, dynamic and supportive culture The Company: Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. A biotechnology innovator since 1980, Amgen has grown to be one of the worldâ€™s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. In 2019, Amgen was named one of the Worldâ€™s Most Admired Companies by Fortune Magazine.
The Role: In this role you will be responsible for a mix of existing portfolio (product indication/safety changes) as well as new registrations for our innovative and biosimilar pipeline. The role involves interaction and negotiation with regulatory agencies in both Australia and New Zealand and close teamwork with the Amgen Brand, QA, pharmacovigilance and supply chain teams. This role will allow you to leverage your understanding of TGA and Medsafe requirements to ensure uninterrupted supply of our products.
Key Responsibilities: Preparation and submission of regulatory applications in Australia and New Zealand for products within agreed timeframes and in compliance with current guidelines Manage, prepare and submit responses to questions within specified timeframes and undertake interactions and negotiations with regulatory authorities to secure and optimise regulatory approvals within agreed strategic parameters Participate in project planning and time-line development for relevant activities Broad expertise regarding regulatory strategy and provide advice regarding potential areas of regulatory concern and new regulatory developments Act as resource regarding regulatory matters to other company personnel Serve as a representative of Regulatory Affairs, and where appropriate the Medical Department, on designated company task forces Prepare/maintain Product Information and Consumer Medicine Information documents and Data Sheets Review of packaging labelling components in accordance with all regulatory requirements Interact with personnel from overseas offices in order to achieve goals and provide advice on the Australian and New Zealand requirements relevant to the development of international regulatory filings. Keep the Senior Manager and/or Director Regulatory Affairs fully briefed in the progress of regulatory projects, identifying and discussing sensitive or critical issues and potential solutions before implementation. Continue to expand knowledge of the regulatory framework by attending applicable courses, seminars, meetings etc, and provide input into the implementation and/or interpretation of legislation and guidelines.
Contribute to company systems development activities and comply with Amgenâ€™s policies, procedures and allie....