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
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
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.
- Website
- http://csl.com/
- Mini-site
- CSL - Australia
- Telephone
- +61 3 9389 1911
- Location
-
45 Poplar Road
Parkville
VIC
3052
Australia
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