Require Associate Director at AstraZeneca
AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination.
Post : Associate Director I - Product Regulatory Affairs
The Regulatory Affairs Director (RAD) is accountable for the development and implementation of the regional (EU or US) and/or global 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 Regulatory Affairs Director possesses strategic leadership skills, has an understanding 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 (GPT), Product Development Teams (PDT) and relevant stakeholders. Has the ability to take on the Global Regulatory Lead (GRL) role for a product/group of products.
• Accountable for the development and implementation, at a regional (EU or US) or global level, of innovative regulatory strategies 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. Strategy should reflect applicable (inter)national requirements.
• Leads the development, communication and updates of the Regulatory Strategy Document (RSD) for assigned products/projects. Ensure appropriate x-functional consultation, peer review and senior stakeholder endorsement. (GRL)
• Accountable for the delivery of regulatory milestones including assessment of the probability of regulatory success together with risk and mitigation measures.
• Lead (GRL)/be part (Regional RAD) of the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities.
• Serves as the single point of contact and Global Regulatory Affairs (GRA) representative on Regional and/or Product Development Teams (PDT)/Global Product Teams (GPT).
• Leads the planning and construction of the global dossier and core prescribing information (GRL).
• Leads the Global Regulatory Strategy team (GRST) with key contributing members from a regional perspective, RA CMC as well as delivery & enablement (e.g. lead RPM, GLG). 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. (GRL)
• Regional RAD is accountable for interacting with the regional commercial and cross-functional teams to ensure business needs are understood within the GRST and to ensure regional commercial engagement with the proposed regulatory strategies/risks/mitigation plans.
• Ensure effective regulatory representation in partnership with appropriate technical experts at all health authority meetings and clear documentation of the discussion and agreements. (GRL accountability in close collaboration with Regional RAD).
• Accountable for product maintenance, supply and compliance activities associated with marketed brands.
• 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.
• Participate in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project.
• Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
• Proactively contributes to the across TA RAD community and/or across GRAPSQA objectives and activities.
• Monitor changes in the regulatory environment, both general and specific to the therapeutic area and support and advice regional and/or Global Product Teams (GPT) or Product Developemtn Teams (PDT) accordingly.
• Partner with marketing company staff to influence developing views/guidance within leading Health Authorities on specific topics of relevance to their project or regulatory more generally.
• Bachelor’s degree in a science related field and/or other appropriate knowledge/experience.
• Previous experience in attending and/or helping a team prepare for a Major Health Authority interactions (e.g. FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre-NDA/BLA, EOP2 meetings etc.).
• More than 5 years of 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.
• 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 or regional 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.
Location : Bangalore
Qualification : B.Pharm, B.Sc
Industry Type : Pharma
Functional Area : Product Regulatory Affairs
End Date : 19th June, 2020
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