- Location
- APAC, AU, Victoria, Melbourne, CSL Limited Melbourne, Australia
- Type
- Full-time
- Department
- Legal
- Seniority
- Manager
- Closing date
- Today
- Source
- Workday
Description
The Opportunity
CSL Seqirus is one of the world’s largest influenza vaccine companies. We also in-license a range of innovator vaccines, medicines and devices to address the unmet needs of patients in Australia and New Zealand. Current therapeutic areas in our in-licensing business include cardiovascular, ophthalmology, pain management, travel vaccines and allergy. Each year, the in-licensing business grows, as additional products are in-licensed.
An exciting opportunity has arisen for an experienced Regulatory Affairs Manager to join the CSL Seqirus in-licensed products team based in Melbourne. Reporting to the Head of Regulatory Affairs APAC In-Licensed Products, responsibilities in this varied role include:
Preparing regulatory strategies for submission of new products or line extensions as well as for ensuring ongoing regulatory compliance.
Planning, preparing and submitting high-quality applications in Australia/New Zealand including Category 1/3 applications, responses to evaluation reports and agency questions.
Collaborating cross-functionally with medical, safety, and commercial teams to develop high-quality PI, CMI, and labelling materials tailored to the Australian and New Zealand markets.
Contributing to the assessment of new in-licensing product opportunities, including regulatory due diligence of new products, providing high-quality regulatory assessments, participating in business presentations and contract negotiations.
Establishing and maintaining excellent relationships and communication with all stakeholders, including regulatory authorities, licensors, market access, medical, marketing, business development, quality, pharmacovigilance and supply chain.
Leading the in-licensing team’s contribution to consultation papers from regulatory authorities, industry bodies and internal departments.
Ensuring audit readiness for internal or external audits by regulatory authorities or partner companies and manage compliance with any required corrective actions.
About you
To be successful in this role, you will bring:
A degree in Biological Science, Allied Medical discipline or Pharmacy
Proven track record of successful regulatory submissions for prescription medicines in Australia and New Zealand, particularly with product life cycle management.
Excellent working knowledge of TGA requirements and guidelines for Australia and Medsafe requirements and guidelines for New Zealand.
Advanced proactive commercial awareness with evidenced application to regulatory strategies.
Well-developed verbal and written communication and interpersonal skills, focused on solutions for the business, customers and patients.
Effective negotiation skills, with demonstrable experience in influencing and persuading internal and external stakeholders to achieve objectives.
Apply now if you're an experienced regulatory affairs professional in the pharmaceutical industry and want to grow in an organisation making a meaningful difference to patients and communities worldwide.
About CSL Seqirus
CSL Seqirus is part of 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. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
Watch our ‘On the Front Line’ video to learn more about CSL Seqirus
