Associate Director, Regulatory Affairs

CSL

21h•Hybrid

About The Position

An exciting opportunity has arisen to join the CSL Seqirus in-licensed products team as a senior regulatory leader. In addition to CSL Seqirus-manufactured influenza and anti-venom products, we also in-license innovator vaccines, medicines and devices to address 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. The future is exciting and full of potential. Your key responsibilities in this senior position include due diligence of new products, development of expert regulatory strategies and preparation of complex submissions and responses to regulatory authorities. This position offers the opportunity to strengthen your leadership experience and the chance to learn and share experiences with other highly skilled colleagues in a collaborative team environment. The ability to work cross-functionally across CSL Seqirus internal teams as well as with our international partner companies is essential and offers a highly rewarding environment for the right candidate. Equally important is your extensive experience in the registration of innovator products and your acute business acumen.

Requirements

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 innovator medicines 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

Responsibilities

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 authority briefing documentation, Category 1/3 applications, responses to evaluation reports and questions
Identify & prioritise any potential risks and associated business impact and develop & implement appropriate mitigation plans
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
Contribute to the assessment of new in-licencing product opportunities, including regulatory due diligence of new products, providing high quality regulatory assessments, participating in business presentations and contract negotiations
Mentor and supervise less experienced team members in the registration of new products or major variations, as well as in the assessment of new in-licensing opportunities
Establish and maintain excellent relationships and communication with all stakeholders, including regulatory authorities, licensors, market access, medical, marketing, business development, quality, pharmacovigilance and supply chain
Lead the in-licensing team's contribution to consultation papers from regulatory authorities, industry bodies and internal departments
Ensure audit readiness for internal or external audits by regulatory authorities or partner companies and manage compliance with any required corrective actions