Regulatory and Quality Affairs Director ANZ

Alexion Pharmaceuticals

Macquarie Park, NSW
Permanent
Full-time

24 days ago

Location: Macquarie Park, Australia Job reference: R-196332 Date posted: 04/04/2024Are you passionate about making a positive and impactful difference to the lives of others and want to add value with your Regulatory/Quality background? Join Alexion as a Regulatory and Quality Affairs Director for ANZ.About AlexionAs a business, we are committed to people. Everyone goes above and beyond to overcome significant challenges and achieve extraordinary outcomes. Our patient first approach informs all our decision-making, and we invest in team and individual development. Ours is an energetic, fast-paced way of working that is solutions focused and collaborative.We will help you expand your skills and knowledge and unlock your best. Working at pace, you'll be challenged and supported to grow - learning from inspiring leadership and exceptional teams who believe in the power of science to make a difference. Every day you will broaden your horizons and skills, finding opportunities to take the initiative and build a meaningful career. Our outstanding learning resources and new diverse career-enhancing opportunities will quickly deepen your personal and professional growth.What you'll doJoin Alexion as a Regulatory and Quality Affairs Director for Australia & New Zealand. This role is pivotal in managing the local regulatory and quality activities for our portfolio products. You will ensure full compliance with all local regulations and corporate policies, acting as the main contact person for regulatory and quality activities, in respect to regulatory authorities.As the Regulatory and Quality Affairs Director, you will lead local regulatory and quality teams, oversee country affiliate input to regulatory strategies, and advise on clinical trial strategy. You will be accountable for all interactions with local Health authorities, oversee local regulatory submissions, and provide local regulatory environment intelligence. You will also oversee the roll out and ongoing compliance to Alexion's Global Quality and Compliance systems and manage and develop / mentor other members of the team.Essential for the role:Significant experience in hands-on Regulatory and/or Quality Assurance management experience from within the pharmaceutical/ biotech industry.Bachelor's Degree in a relevant life science fieldThorough knowledge of applicable local and global regulatory requirements required for GXP compliance.Extensive knowledge in a broad range of pharmaceutical regulatoryactivities and Quality Systems.Strong Management and leadership abilityExceptional communication and interpersonal skillsAbility to work globally in a matrix environmentAbility to influence senior management, peers and other colleaguesDesirable for the role:Advanced degree (PharmD or PHD)Why Alexion?At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translate into innovative breakthroughs for patients.We want to unlock your potential and inspire you to be your best, challenging you to expand your horizons, extend your knowledge, and grow to your fullest.So, what's next?Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it's yours.If you're curious to know more then please reach out to Danielle Jones. We welcome your application.Where can I find out more?
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Our websiteAstraZeneca in Australia has been formally recognised as an Employer of Choice for Gender Equality by the Workplace Gender Equality Agency (WGEA). As an organisation we stand with confidence on our gender equality initiatives including pay equity, leadership development programs, and zero tolerance for gender-based harassment. This achievement exemplifies our commitment to building high performing, inclusive and diverse teams that collaborate across our enterprise, aligned to our values and strategic priority of being a Great Place to Work.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Alexion Pharmaceuticals

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