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Regional Regulatory Manager, ANZ Region

Employer
CSL - Australia
Location
Broadmeadows, AU
Salary
Competitive
Start date
16 Jan 2022
Closing date
5 Feb 2022

View more

Discipline
R & D , Scientific
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

We have an opportunity available for a Regional Regulatory Manager to join our Regulatory Affairs team. You will manage all regional regulatory strategic and operational tasks for a range of products in the assigned Therapeutic Area (TA). You will cover both licenced products and products under development in the ANZ Region.

Responsibilities:

  • Manage regulatory submissions, including new licence applications, variations, PSUR
  • Develop regional regulatory strategies considering local and global requirements
  • Foster working relationships with regional Regulatory Agencies to achieve positive outcomes for CSL Behring.
  • Be a Subject Matter Expert on regional regulatory procedures and HA requirements
  • Participate in meetings to support product management responsibilities within ANZ Region
  • Manage partners in cross-functional projects


Qualifications:

  • A degree in Biological or Medical Science or Pharmacy, preferably with a post-graduate qualification.
  • 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.
  • Strategic and ability, complemented by a "hands-on" operational approach and business planning orientation.
  • Customer service focus.
  • Working knowledge of regulatory guidelines and legislative requirements in ANZ and preferably other markets
  • Knowledge of regulatory affairs discipline including an understanding of the new pharmaceutical product development process and requirements for major regulatory applications.
  • Flexibility to work independently and in teams in a global matrix organisation.


Apply now to join an ASX Top 5 organisation that directly helps patients and public health in Australia and overseas!

Applications close 4 February 2022

Please include a covering letter addressing the selection criteria.

CSL is an Equal Opportunity Employer

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!

Company

Find out more about working for our company

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Brief Company Description; 

Driven by Our Promise

Delivering on promises is what we do at CSL.

Over a century ago in Melbourne, Australia, we made a promise to save lives and protect the health of people who were stricken with a range of serious and chronic medical conditions. Today, as a leading global biotech company, that same promise has never been stronger. We develop and deliver innovative biotherapies and influenza vaccines that save lives, and help people with life-threatening medical conditions live full lives. We are driven by our deep passion to serve hundreds of thousands of patients and other stakeholders around the world.

Company info
Website
Mini-site
CSL - Australia
Telephone
+61 3 9389 1911
Location
45 Poplar Road
Parkville
VIC
3052
Australia

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