Associate Director, Regulatory Affairs In-Licensing
Job Type: Part time
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 at our new CSL Head Office in Melbourne.
CSL Seqirus in-licenses vaccines, pharmaceutical products and devices from our partner companies to ensure 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. Each year, the in-licensing business grows, as additional products are in-licensed. The future is exciting and full of potential.
This role does not currently have direct reports. There may, however, be the opportunity for one direct report in the future.
- Manage a portfolio of products covering various therapeutic areas
- Develop and execute regulatory strategies to achieve successful regulatory outcomes, in accordance with business goals, including development of innovative strategies as needed
- Plan, prepare and submit high quality applications in Australia/New Zealand including regulatory agency briefing documentation, Category 1/3 applications, responses to evaluation reports and agency questions
- Identify & prioritise any potential risks and associated business impact and develop & implement appropriate mitigation plans
- Prepare and maintain Product Information, Consumer Medicine Information and labelling materials
- Perform due diligence of new in-licensing product opportunities and provide high quality regulatory assessments of these opportunities
- Mentor and supervise less experienced team members in the registration of new products or major variations, as well as in the due diligence of new product opportunities
- Establish and maintain excellent relationships and communication with all stakeholders, including Health Authorities, Licensors, Health Economics, Medical, Marketing, Business Development, QA, Pharmacovigilance and Supply Chain
- 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
- Provide input into monthly reports and ensure that regulatory information management and tracking systems are updated to maintain regulatory compliance.
Qualifications, skills and experience:
- Tertiary qualification in a biological science, allied medical discipline or pharmacy
- Extensive regulatory experience with prescription medicines in Australia and New Zealand, including negotiations with TGA and Medsafe
- Extensive experience in the submission and registration of new chemical entities or major variations involving clinical data
- Excellent working knowledge of therapeutic goods 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 problem-solving skills
We look forward to receiving your application.
Applications must address the selection criteria above and include a current CV and covering letter.
Applications close October 4th, 2023
Employment screening, including criminal history, medical assessment, confirmation of experience and stated qualifications, Australian working rights and other relevant checks form part of the candidate suitability.
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.
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.
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