Associate Director, Regulatory Regional Lead Au/nz

2 days ago

Melbourne, Australia CSL Full time

We have an opportunity available for an Associate Director, Regulatory APAC Region Lead to join our team. You will be a team leader responsible for executing all regional regulatory strategic and operational tasks for licenced products and development projects/products in the region.

You will establish and maintain working relationships with the respective regional Regulatory Agencies and other external stakeholders.

Reporting to the APAC TA Lead, you will:

- Be a Subject Matter Expert on regional, regulatory procedures and HA requirements and primary regional contact for strategic oversight on the allocated TA for the Region
- Ensure that documentation for submissions in the region meet the content and format requirements for the regional regulatory authorities and is submitted according to agreed schedules.
- Provide input to budgets, to resource plans and monitor activities and progress to ensure strategic goals for the CSL Behring products in the region are achieved.

Your Experience:

- A degree in Biological or Medical Science or Pharmacy, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous.
- At minimum 5 years' experience in the pharmaceutical industry, preferably in Biologics in the areas R&D, quality, manufacturing, Regulatory Affairs.
- At least 5 years of regulatory experience in a regulatory authority facing role, supported by additional pharmaceutical /industry experience.
- Understanding of the scientific principles and technical requirements relevant to the development of a pharmaceutical product.
- Understanding of the principles of GMP, GCP and GLP.
- Demonstrated working knowledge of regulatory guidelines and legislative requirements of both international and (respective) regional Regulatory Authorities.

Applications Close on 10 November 2024

**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

**About CSL Behring**:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

**Do work that matters at CSL Behring**:

  • ▷ (Apply Now) Associate Director - Regulatory Affairs

    4 weeks ago

    Melbourne, Australia Gilead Sciences, Inc. Full time

    For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer – working relentlessly to develop therapies that help improve lives and to ensure...

  • Associate Director Regulatory Enablement and

    2 days ago

    Melbourne, Australia NAB - National Australia Bank Full time

    **Work type**: Fixed term Full time, Permanent Full time **Location**: VIC- Melbourne CBD - **Showcase your superior eye for detail & regulatory compliance insights**: - **Outstanding opportunity to progress your career in this highly engaged team**: - **Hybrid way of working with 2-3 days in 395 Bourke Street for networking and collaborating**: - **6...

  • Real Estate Manager, Au/nz

    2 weeks ago

    Melbourne, Australia Lululemon Full time

    Who we are lululemon is an innovative performance apparel company for yoga, running, training, and other athletic pursuits. Setting the bar in technical fabrics and functional design, we create transformational products and experiences that support people in moving, growing, connecting, and being well. We owe our success to our innovative product, emphasis...

  • Regulatory Affairs Specialist

    7 days ago

    Melbourne, Australia ProductLife Group Full time

    Specific Activities and Responsibilities: Must have expertise in Health Authority communications for Initial filings, LCM Activities and for variation submissions.Must have experience and thorough knowledge of the process of submissions at HA without missing any detail or deadline.Must be competent with the current changes and regulations from the HA.Will be...

  • Regulatory Policy Lead

    2 weeks ago

    Melbourne, Australia D'Arcy Weil Full time

    Melbourne, AU - Leading Energy Brand - Flexible Working Environment **Through an industry-leading commitment to innovation, the company is investing in Australia’s energy future by developing the full portfolio of energy resources, including cleaner energy, renewables, and energy efficiency, looking ahead by creating new products and services to help...

  • Regional Regulatory Manager Anz

    2 hours ago

    Melbourne, Australia CSL Behring Full time

    **The Opportunity**: Due to an internal promotion within CSL we are looking for a Regional Regulatory Manager ANZ. Reporting to the Therapeutic Area Lead - Regulatory Affairs you will be responsible for all regional regulatory strategic and operational tasks for a range of products in the assigned Therapeutic Area. Your responsibilities will cover products...

  • Dsv Cadet Program Au

    7 days ago

    Melbourne, Australia DSV Full time

    If you are a current DSV employee and interested in a position in another country, please contact your Human Resource representative to discuss the process and requirements of applying. Job Req Number: 86730 Time Type: Full Time Are you ready to dive into an exciting career with a global company that’s all about growth, learning, and making an impact?...

  • Associate Director, Sustainability Reporting

    2 hours ago

    Melbourne, Australia NAB - National Australia Bank Full time

    **Work type**: Fixed term Full time **Region**: VIC- Melbourne CBD - Do you love problem solving and taking on a new challenge? - Support our customers to manage their transition and build resilience - Be supported to grow your career at NAB **In this Associate Director, Sustainability Reporting role you will**: - Own a workstream in a major regulatory...

  • Associate Director, Controls

    1 week ago

    Melbourne, Australia NAB - National Australia Bank Full time

    **Work type**: Permanent Full time **Region**: VIC- Melbourne CBD - **Seeking experienced Audit / Assurance / Risk professionals to join the team based in Melbourne.**: - **Play a pivotal role in improving NAB’s risk and control environment and contribute to NAB achieving its strategic priorities.**: - **We are empowered to make a positive difference in...

  • Associate Director, Eu Delivery and Regulatory

    2 hours ago

    Melbourne, Australia NAB - National Australia Bank Full time

    **Work type**: Permanent Full time **Location**: NSW- Sydney CBD, VIC- Melbourne CBD - **Great opportunity to build and progress your career working towards a critical priority for NAB**: - **Develop your capability as an expert in your field, offering direction and support to the business and engaging with external stakeholders**: - **Committed to working...