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Director, Regulatory Affairs, Australia

Moderna - Sydney, NSW

Health, Medical & Pharmaceutical
Source: uWorkin


The Role

The Director of Regulatory Affairs - Australia based in Sydney, Australia will have the opportunity to lead the regulatory strategy with TGA and provide regulatory support to the VP of RA-International and the General Manager of Moderna’s Australian Affiliate. This is a newly created role intended for a forward looking, creative and agile regulatory Director able to anticipate and address the challenges involved in supporting the Health Agency interactions in Australia for messenger RNA therapeutics as unprecedented new drug modality. The Director will provide regulatory Clinical and CMC support across the Therapeutic Areas including Infectious Diseases. Their support includes but is not limited to managing the regulatory interactions and new drug submissions in Australia. This person will work closely with the business in Australia to secure the appropriate operating licenses and provide the regulatory guidance to support the overall business plans including market access.

Here's What You’ll Do

  • Develop and contribute to content, format and accountability for regulatory submissions and related supplements and amendments, including Australian regulatory documents such as meeting requests, briefing books, orphan drug designations, DSURs, NDS, etc.)
  • Work with VP-RA International and Global Regulatory Teams regarding the development and execution of regulatory strategy in Australia.
  • Responsible for coordinating aspects of regulatory submissions relevant to assigned projects or programs
  • Identify and assess regulatory risks for assigned projects or programs
  • Serve as Primary contact to TGA and other regional health authorities, as appropriate
  • Ability to work both independently and within project teams, committees, etc. to achieve business goals and objectives
  • Prepare and deliver effective communications and presentations for external and internal audiences

Here’s What You’ll Bring To The Table
  • Degree in Life Science or related discipline, advanced degree preferred (PharmD, MSc, PhD)
  • 10+ years of experience in the Pharmaceutical industry. 7+ years of experience in Regulatory strategy
  • Strong knowledge of current Australian, and International regulations (e.g. New Zealand and others) related to the clinical, nonclinical, and CMC development
  • Strong experience with CTD format and content regulatory filings
  • Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance in the EU and International countries
  • Creates and maintains the Australian-specific parts of regulatory dossiers including Information for Professionals and Patient and Packaging Information as well as National Succinct Statement.
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
  • Ability to work independently to manage multiple projects in a fast-paced environment
  • Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones
  • Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Project Teams and senior management, as relevant
  • Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned. Fluency in English is required.
  • A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative

About Moderna

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com .

Moderna is a smoke-free, alcohol-free and drug-free work environment.

  • Sydney, NSW

    Health, Medical & Pharmaceutical


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