Senior Regulatory Affairs Director - Oncology
Are you a strategically focused Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on At AstraZeneca work with diverse minds, all united by a shared passion to learn, grow and discover. Within Oncology Regulatory Science and Strategy (ORSS) we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. The Senior Regulatory Affairs Director (SRAD) serves as the Franchise Global Regulatory Lead (GRL) on complex programs with multiple indications. You will lead the development and implementation of the global regulatory strategy for a product/group of products of increasing complexity. The SRAD has the ability to function in dual capacity by also serving as a regional lead based on their location. You will ensure the strategy is aligned to deliver rapid approval with competitive labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. The SRAD establishes external relationships with key regulatory stakeholders, leveraging these to maintain competitive advantage. You will be viewed as a senior leader within the regulatory community and provide team leadership, coaching and mentorship to the larger Global Regulatory Strategy Team. We are looking for a Senior Regulatory Affairs Director to sit out of the Gaithersburg, MD office! Typical Accountabilities, what you will be doing: * Accountable for leading the development and implementation of the global regulatory strategy for a product/group of products spanning multiple indications. Includes providing Regulatory leadership on Franchise products with multiple indications and development programs. May also serve as a Regional Regulatory Affairs Director (RAD) depending on location. * Ensures that the strategy is designed to deliver rapid approval with competitive labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. * Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labelling and members of the submission and execution team. Participate in coaching, and performance feedback to members of your GRST. * Lead the objective assessment of emerging data against aspirations and update senior management on project risks/ mitigation activities. * Represent Regulatory Affairs on Global Product Teams (GPTs) providing strategic regulatory advice and accountable for all Regulatory activities. * Accountable for the delivery of all regulatory milestones on your team including assessment of the probability of regulatory success based on a thorough assessment of regulatory risks and mitigations. Lead preparation of the regulatory strategy document and target product labeling. * Demonstrate strategic leadership skills contributing to effective product development. * Participate in and promote novel regulatory initiatives internally and engage externally on the corresponding topics as needed. Lead the development of novel regulatory tools and technology. * Ensures appropriate planning and construction of the global dossier and core prescribing information led by the respective teams. Accountable for product maintenance, supply and compliance activities associated with marketed brands. * Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance. Education, Qualifications, Skills and Experience: Essential: * An advanced degree in a science related field and/or other appropriate knowledge/experience. * Previous demonstrated experience of regulatory drug development including product approval/launch. Successful leadership to at least one major regulatory approval at a global level including leading response team and labeling negotiations is desired. * Previous experience leading major health authority interactions. * Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. Experience in relevant therpay area (small molecules & biologics) is preferred. * Proven leadership experience. * The ability to think strategically and critically and evaluate risks to regulatory activities. * Deep undestanding of global regulatory science and will integrate with project strategy. You have a long standing experience of overall drug/biologic development processes and strategies for high profile, complex or novel development programs. Desirable: * Previous experience with FDA advisory committee and EMA oral explanation would be a plus. * Previous expereince working on due diligence activities and in a business alliance environment. * Ability to work strategically within a complex, business critical and high-profile development program. Next steps, if the role looks suitable to you please apply! 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 authorisation and employment eligibility verification requirements. AstraZeneca has taken critical steps to protecting colleagues, loved ones, and patients from COVID-19 and its variants. COVID-19 vaccination is required for all US employees, and weekly PCR COVID-19 testing is required for those who are unvaccinated or have an approved accommodation. Salary : Negotiable This employer is a corporate member of myGwork, the business community for LGBTQ+ professionals, students, inclusive employers & anyone who believes in workplace equality.