Principal Associate, Regulatory Affairs
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What you'll do
- Work with the manager to develop regulatory strategies for new and existing products.
- Plan, prepare and submit high-quality applications in Australia/New Zealand, including new product applications (with manager) and variation applications (independently) and respond to agency questions.
- Evaluate change controls for regulatory impact and develop appropriate regulatory strategies to support product lifecycle management and regulatory compliance.
- Support regulatory due diligence for new in-licensing opportunities.
- Establish and maintain strong working relationships and communication with all key stakeholders, including regulatory authorities, licensors, Commercial, Medical, Market Access, Quality, Pharmacovigilance and Supply Chain.
- Lead the in-licensing team’s contribution to consultation papers from regulatory authorities and industry bodies.
- Review and update SOPs, guidelines, work instructions and contribute to global system and process improvement projects.
- Support the review of business agreements including licensing agreements, quality agreements and pharmacovigilance agreements.
- Collaborate 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.
- Effectively manage regulatory aspects of medicine shortages to ensure compliance.
- Maintain regulatory databases and records to ensure accuracy, completeness, and compliance with internal SOPs and regulatory requirements.
- Provide regulatory support during inspections and audits, including preparation, document management, and follow-up of corrective actions.
What they're looking for
- A degree in Biological or Medical Science or Pharmacy.
- Proven track record of successful regulatory submissions for prescription medicines in Australia and New Zealand.
- Strategic and tactical thinking ability, complemented by a "hands on" operational approach and strong commercial awareness.
- Ability to identify the impact of regulatory changes to other functions and to communicate changes, regulatory strategy and needs.
- Ability to handle multiple projects and demonstrated ability to meet milestones.
- Highly effective written and verbal communication skills and presentation skills.
- Excellent planning, organising and time management skills.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Role
CSL, a global biotech company, provides lifesaving products to patients in more than 100 countries. An exciting new opportunity has arisen in the CSL Seqirus APAC In-Licensing Regulatory Affairs team for an experienced regulatory affairs professional in the role of Principal Associate. Based in Melbourne, the Principal Associate supports product registrations and maintenance in Australia and New Zealand, as well as new product opportunities.
Responsibilities
In this role you will:
Work with the manager to develop regulatory strategies for new and existing products.
Plan, prepare and submit high-quality applications in Australia/New Zealand, including new product applications (with manager) and variation applications (independently) and respond to agency questions.
Evaluate change controls for regulatory impact and develop appropriate regulatory strategies to support product lifecycle management and regulatory compliance.
Support regulatory due diligence for new in-licensing opportunities.
Establish and maintain strong working relationships and communication with all key stakeholders, including regulatory authorities, licensors, Commercial, Medical, Market Access, Quality, Pharmacovigilance and Supply Chain.
Lead the in-licensing team’s contribution to consultation papers from regulatory authorities and industry bodies.
Review and update SOPs, guidelines, work instructions and contribute to global system and process improvement projects.
Support the review of business agreements including licensing agreements, quality agreements and pharmacovigilance agreements.
Collaborate 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.
Effectively manage regulatory aspects of medicine shortages to ensure compliance.
Maintain regulatory databases and records to ensure accuracy, completeness, and compliance with internal SOPs and regulatory requirements.
Provide regulatory support during inspections and audits, including preparation, document management, and follow-up of corrective actions.
Qualifications and Experience
To be successful in this role you will need:
A degree in Biological or Medical Science or Pharmacy.
Proven track record of successful regulatory submissions for prescription medicines in Australia and New Zealand.
Strategic and tactical thinking ability, complemented by a “hands on” operational approach and strong commercial awareness.
Ability to identify the impact of regulatory changes to other functions and to communicate changes, regulatory strategy and needs.
Ability to handle multiple projects and demonstrated ability to meet milestones.
Highly effective written and verbal communication skills and presentation skills.
Excellent planning, organising and time management skills.
If you want to contribute to helping patients in Australia and New Zealand, apply now!
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
Company
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