Director Regulatory Intelligence

About the Company

Responsibilities

• ● rea regulatory intelligence, interpretation, and impact analysis of the emerging external regulatory and competitive landscape to support risk assessment and portfolio decisions. You will partner closely with senior regulatory leaders and cross-functional intelligence groups to anticipate shifts in guidance and identify precedents that unlock smarter development pathways. In an agile, collaborative environment, you will help convert complex data into action that shortens timelines, strengthens labels, and improves patient outcomes. The RID must possess the ability to assess the impact of key regulatory developments and communicate key insights to inform development strategies. Thus, the RID must have a strong background in drug and biologic development regulatory affairs and effective communication skills. The RID will:
• ● Conduct analysis and impact assessment of Regulatory Intelligence across the portfolio (e.g., precedents, relevant guidance, approval summaries) and communicate findings to key stakeholders and senior leaders, including R&I Regulatory Affairs VP, Executive Regulatory Science Directors, and Global Regulatory Leads.
• ● Collaborate with Regulatory Affairs teams to conduct bespoke regulatory research and provide the Regulatory Intelligence aspect of disease area- and product-specific Regulatory strategies.
• ● Collaborate with other regulatory intelligence groups within AZ to interpret EMA, FDA, and/or other global Health Authority trends, perspectives, reports, activities, etc.
• ● Identify regulatory opportunities for portfolio acceleration, e.g., novel regulatory pathways, opportunities for adoption of novel technology or innovative evidence generation methods.
• ● Work closely with Clinical Information Science and Commercial Intelligence and other R&I experts to provide regulatory interpretation and analysis to emerging disease area information.
• ● Liaise with global regulatory policy and drive coordination within R&I to respond to draft Health Authority guidance documents and ensure R&I priorities are reflected in external regulatory policy engagement.
• ● Collaborate with International, China, and Japan RADs regarding disease area-specific guidance and regulatory intelligence aspects in each region, contributing to overall Regulatory landscape per disease.
• ● Identify opportunities and to leverage artificial intelligence and other new tools to simplify business process; drive implementation and adoption of novel technologies to enhance efficiency and facilitate regulatory intelligence activities. Required Skills and Experience:
• ● Advanced degree in a science related field and/or other appropriate knowledge/experience .
• ● At least 7 years of demonstrated ability in regulatory strategy, intelligence, and/or policy.
• ● Detailed understanding of US and European regulatory affairs and an understanding of the broader regulatory ecosystem.
• ● Proficiencies in data impact analysis, strategic thinking, creative problem solving, and excellent oral and written communication skills.
• ● Ability to evaluate the impact and drive change of key Regulatory Intelligence on disease area and project strategy.
• ● Ability to discern and communicate relevant Regulatory news to key collaborators and senior leaders
• ● Solid understanding of Regulatory Intelligence Tools.
• ● Solid understanding of the commercial aspects of BioPharmaceutical development
• ● In-depth knowledge of the R&I therapeutic area
• ● Broad background of experience working in pharmaceutical business and prior experience in leading competitive intelligence within the pharmaceutical industry or in associated industries
• ● Critical thinking on current global regulatory science trends and questions with a good understanding of the corresponding scientific and clinical components.