Manager Regulatory Affairs

**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/](https://www.csl.com/) and CSL Plasma at [https://www.cslplasma.com/](https://www.cslplasma.com/). **Our Benefits** For more information on CSL benefits visit [How CSL Supports Your Well-being | CSL](https://www.csl.com/careers/your-well-being). **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](https://www.csl.com/accessibility-statement). **Watch our ‘On the Front Line’ video to learn more about CSL Seqirus**