Director Regulatory Affairs RIA at AstraZeneca Gothenburg
At AstraZeneca, we lead our industry in the development of a strong and varied pipeline. This means our people are here to win, we give you a breadth of opportunities to be curious and do cutting edge, unique work that has significant impact on science and medicine. The Global Regulatory Affairs Therapeutic area team is a strategic function and plays a key role within the Global Product Teams who work cross functionally to gather expertise and knowledge that informs our drug development programs. They are ultimately responsible for ensuring the pieces fit together to deliver for patients and physicians and provide therapy area regulatory expertise that supports regulatory interactions across the globe to secure fast submissions for our medicines in development. Due to expansion, the Respiratory, Inflammatory and Autoimmune (RIA) team is currently seeking an experienced Regulatory Affairs Senior Director to join us for a one-year assignment starting in the beginning of 2019.About the consulting assignment
The Regulatory Affairs Director (RAD) is accountable for the development and implementation of the regulatory strategy for a product/group of products and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. The RA Director possesses strategic leadership skills, understands of regional (US or EU) and/or global regulatory science and overall drug/biologic development processes and strategies. Experience and knowledge of the disease area is an important enabler to being able to influence cross-functional discussions with regional and/or Global Product Teams, Investigational Product Teams and relevant stakeholders and has the ability to take on the Global Regulatory Lead role for a product/group of products.
• Leads the development and implementation of innovative global strategies of increasing complexity to maximize the likelihood of regulatory success.
• Accountable for the delivery of all regulatory milestones including assessment of the probability of regulatory success together with risk analysis and mitigation measures.
• Leads the planning and construction of the global dossier and core prescribing information
• Accountable for product maintenance and compliance activities associated with marketed brands.
• Serves as the single point of contact and Global Regulator Affairs (GRA) representative on Product Development Teams (PDT)/Global Product Teams (GPT).
• Leads the Global Regulatory Sub-team (GRST) with key contributing members from a regional perspective, emerging markets, Reg CMC as well as delivery & enablement.
• Partner with marketing company and regional regulatory affairs staff to influence developing views/guidance within leading Health Authorities on specific topics of relevance to their project or regulatory more generally.
• Monitor changes in the regulatory environment, both general and specific to the therapeutic area and support and advise Global Product Teams (GPT) accordingly.
• Capability to lead key cross-department or cross-functional projects on behalf of Global Regulatory Affairs (GRA) when necessary.
• Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
• Participate in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project.
• Provide a regional focus and interact with commercial to understand business needs and to ensure regional commercial engagement with the proposed regulatory strategies
Requirements – Education and Experience:
• Advanced degree in a science related field and/or other appropriate knowledge/experience.
• Must have previous experience in leading Major Health Authority interactions (e.g. FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre-NDA/BLA, EOP2 meetings etc.).
• >10 years’ experience or equivalent of regulatory drug development including product approval/launch. Expert knowledge of regulatory affairs within one or more relevant therapeutic areas. In this case, any previous experience in vaccines/infectious disease is also useful.
• Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority.
• Experience in relevant therapy area (small molecules & biologics) is preferred.
• Proven leadership and program management experience.
• Ability to think strategically and critically evaluate risks to regulatory activities.
• Ability to work strategically within a complex and business critical development program.
• Successful contribution to a major regulatory approval at a global level.
• A scientific and clinical understanding of the regulatory sciences.
• Must demonstrate competencies of: strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.
AstraZeneca is a major international healthcare business engaged in the research,
development, manufacture and marketing of prescription pharmaceuticals and the
supply of healthcare services. AstraZeneca is proud to offer a unique workplace
culture that inspires innovation and collaboration. Co-workers are empowered to
express diverse perspectives - and are made to feel valued, energized and rewarded
for their ideas and creativity.