Career Category

Job Description

Join our collaborative & dynamic Regulatory Affairs team.  Work on new pipeline & existing portfolio of products. Fantastic Career growth opportunity,

• Great career Opportunity - Full-time, Permanent role 
• Great team environment:  collaborative, dynamic and supportive culture 
• Based in Macquarie Park with onsite parking

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 world’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 World’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 Amgen’s policies, procedures and allied documents.
• Be aware of and work within company policies and industry (Medicines Australia & Medicines New Zealand) guidelines and apply Amgen Values in daily activities
• Provide regulatory advice on promotional materials based on an understanding of the Medicines Australia and/or Medicines New Zealand Codes

Qualifications, Skills, Knowledge and Experience:

• Degree in pharmacy, science, life/biomedical sciences
• Minimum 2 years’ experience in Regulatory Affairs (prescription pharmaceutical sector for biotechnology products) across Australian and New Zealand markets
• Experience working within a pharmaceutical and/or in-licensing pharmaceutical company 
• Working knowledge of biologic development process and Regulatory Affairs environment 
• Experience in pharmaceutical GMP controlled environment (desirable)
• A strong working relationship with TGA/Medsafe is essential  
• Work rights for Australia mandatory

If you are seeking a genuine career opportunity where you can truly make a difference to better serve patients and progress against our aspiration to be the world’s best human therapeutics company, then we’d love to hear from you. 

We prefer to deal with you directly and have not engaged an agency for this role recruitment, so if you’re interested in this unique opportunity, please apply asap online today. Confidentiality assured.

Please submit your resume and cover letter asap.

No agencies please.
 

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Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.