Regulatory Affairs Manager

CSL

Location: Docklands

Job Type: Full time

Posted


Job Description

The Opportunity

Reporting to the Head Regulatory Affairs APAC In-Licensed Products, you will be part of the CSL Seqirus APAC In-Licensing Regulatory Affairs Team. You will be based initially at our Collins Square office in Melbourne CBD, then at our new CSL Head Office in Melbourne.

CSL Seqirus in-licenses vaccines, pharmaceutical products and devices from our partner companies to guarantee a comprehensive range of products is available to meet the needs of our patients in Australia and New Zealand. Current therapeutic areas in our in-licensing business include neurology, ophthalmology, pain management, travel vaccines and allergy.

The Role

  • Be responsible for a portfolio of products covering various therapeutic areas
  • Develop and implement regulatory strategies for products in your portfolio
  • Develop strategies to address perceived deficiencies in dossiers to achieve a successful registration
  • Plan, prepare and submit high quality applications in Australia/New Zealand including Category 1/3 applications, responses to questions, and regulatory agency briefing documentation.
  • Contribute to or lead the regulatory affairs assessment and due diligence of new in-licencing opportunities
  • Maintain awareness of products in your portfolio to assist with communication to Health Economics, Medical, Marketing and Business Development colleagues at all stages of the in-licencing process and product life-cycle
  • In collaboration with In-Licencing partners and company partners maintain up-to-date product labelling (PI, CMI,
  • Lead the In-Licensing team's contribution to consultation papers from agencies, industry bodies and internal departments
  • Lead continuous improvement activities and processes for the In-Licensing team
  • Build relationships with internal customers, licensors and regulatory agencies

Your skills and experience

  • Tertiary qualification in a biological science, allied medical discipline or pharmacy
  • Extensive experience in regulatory affairs in the pharmaceutical industry
  • Excellent working knowledge of regulatory affairs legislation and guidelines for Australia and New Zealand
  • Excellent communication and interpersonal skills, with a business solution and customer focus
  • Excellent negotiation skills, persuasive writing skills and strong problem-solving skills

How to apply

Apply now for a role now with a varied remit in an organisation going through considerable investment and change. Please include a CV and Cover Letter in your application.

Our Benefits

CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving our goals. Learn more about some of the benefits you can participate in when you join CSL Seqirus.

About CSL Seqirus

CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. In Australia, CSL Seqirus is also a leading provider of speciality pharmaceuticals and other essential vaccines. Learn more about CSL Seqirus.

We want CSL Seqirus to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.

Do work that matters at CSL Seqirus!

About Us

Our Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

About Seqirus

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

We want Seqirus to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.

Do work that matters at Seqirus!

You’ve got this!