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April

Global Regulatory Affairs Cmc Team Lead

CSL Behring - Melbourne, VIC

Any Industry
Source: uWorkin

JOB DESCRIPTION

With operations in 35+ nations and ~ 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

The Opportunity

We have an exciting opportunity available for a Global Regulatory Affairs (GRA) CMC Team Lead to join our team, based at Broadmeadows. In this position, you will manage, oversee and develop a dynamic team of CMC regulatory professionals and be accountable for all CMC regulatory activities related to product development, registration and license maintenance for the products handled by the team. Additionally, as a people leader in this position, you will be part of the global GRA CMC extended leadership group.

For the product portfolio overseen by the team, you will be accountable for development and implementation of global CMC regulatory strategies for development and life cycle projects with a view to reach approvals in the most efficient way, while ensuring compliance with global regulatory requirements.

Additionally, you may have operational and strategic CMC regulatory responsibility for products assigned to you, and in this capacity you will be a permanent member of the Global Regulatory Affairs Strategy Team and/or relevant CMC Regulatory Sub-Team related to the assigned products. For established products which are no longer in clinical development you may be appointed as Global Regulatory Lead and will be accountable for successful product lifecycle management.

Furthermore, you will be responsible for the compilation and maintenance of facility and equipment information for regulatory submissions and act as the primary GRA contact during GMP inspections and for preparation of inspections.

To be successful

  • University degree in natural sciences (MS or equivalent), a Ph.D. or further degree, e.g. in Regulatory Affairs is advantageous.
  • Minimum of 7 years’ experience in the biotech or pharmaceutical industry, with at least 5 years in Regulatory Affairs.
  • Minimum of 3 years experience in leading and managing a team or matrix team, setting clear direction, holding people accountable and thus fostering a result oriented and collaborative team working environment.
  • Sound knowledge in natural sciences with a focus on biological medicinal products.
  • Sound technical regulatory expertise and understanding of the regulatory framework in more than one key region (US, EU, Japan, CH, and Australia).
  • Knowledge in Good Manufacturing Practice or related areas would be highly regarded.
  • Experience in working cross-culturally within a complex and matrix environment.
  • Excellent communication, project management, planning, problem solving and presentation skills.
  • Strong team player with a demonstrated ability to develop constructive and effective relationships with peers and management.

Applications must address the selection criteria above and include a current CV and covering letter.

Applications close 2 April 2021

Employment screening, including criminal history, medical assessment, confirmation of experience and stated qualifications, Australian working rights and other relevant checks form part of the candidate suitability evaluation process.

Worker Type:

Employee

Worker Sub Type:

Regular

Posted 7 Days Ago

Full time

R-130984

About Us

With operations in 35+ nations and ~ 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

If you are an individual with a disability and need a reasonable accommodation for any part of the

CSL does not accept referrals from employment businesses and/or employment agencies with respect to the vacancies posted on this site. All employment businesses/agencies are required to contact CSL's human resources department to obtain prior written authorization before referring any candidates to CSL. The obtaining of prior written authorization from the human resources department is a condition precedent to any agreement (verbal or written) between the employment business/ agency and CSL. In the absence of such written authorization being obtained, any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of CSL. CSL shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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