Successful candidates will be AstraZeneca Employees and will be located at AstraZeneca's MedImmune strategic science center in Gaithersburg, Maryland. MedImmune is the worldwide biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines.
The Regulatory Affairs Senior Director is accountable for leading the development and implementation of the global regulatory strategy for a product/group of products and for ensuring that the strategy is designed to deliver 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 Senior Director possesses strategic leadership skills, has a deep understanding of global regulatory science and overall drug/biologic development processes and strategies. Experience and knowledge of the disease area is critical to being able to influence cross-functional discussions with Global Product Teams (GPT) and relevant stakeholders. Dependent on the project phase and its complexity, the RA Senior Director may function in dual capacity by delivering the overarching global regulatory strategy as well as serving as a regional lead based on their location, respectively.
* 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 and patients.
* Develops a global regulatory strategy that is reflective of applicable domestic and international requirements.
* Owns the planning and construction of the global dossier and core prescribing information.
* Conducts regulatory risk planning and mitigation.
* Develops and implements innovative strategies to maximize the likelihood of regulatory success.
* 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, RA CMC as well as delivery & enablement. Through the GRST, ensures that regional regulatory needs are identified and incorporated into an optimum Global Regulatory Strategy that in turn contributes to the Global Product Development Plan.
* Accountable for the delivery of all regulatory milestones including assessment of the probability of regulatory success together with risk mitigation measures.
* The Global Regulatory Leader (GRL) is also accountable for product maintenance, supply and compliance activities associated with marketed brands.
* Lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities.
* 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.
* Lead the regulatory staff working on a product/project to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality.
* Ensure effective regulatory representation in partnership with appropriate technical experts at all health authority meetings and clear documentation of the discussion and agreements.
* Develop, communicate and update the Regulatory Strategy Document for assigned products/projects. Ensure appropriate consultation and peer review.
* 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 Regulator 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.
* Capability and credibility in complex, business critical projects and ability to cope with ambiguity.
* Has developed and actively uses external relationships with key stakeholders to reinforce AstraZeneca's regulatory credibility.
* Dependent upon development phase and project complexity, the GRL may provide a regional focus in addition to being the overall global lead. In a regional role, accountable for interacting with commercial and cross-functional teams to ensure business needs are understood and to ensure regional commercial engagement with the proposed regulatory strategies/risks/mitigation plans.
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 therapeutic areas.
* 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 designated therapeutic 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, business critical and high profile 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.