Director Regulatory Intelligence

The Regulatory Intelligence Director role sits at the intersection of competitive insight, regulatory science, and portfolio strategy, translating emerging signals into clear choices for our pipeline and marketed assets. Based at AstraZeneca’s dynamic R&D site in Gaithersburg, MD, you will be part of the Strategy and Innovation Team, collaborating with global regulatory strategists, medical writers, labeling, data analytics, and policy and intelligence experts.

Responsibilities

• 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, and activities.
• 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, Commercial Intelligence, and other R&I experts to provide regulatory interpretation and analysis of emerging disease area information.
• Liaise with global regulatory policy and drive coordination within R&I to respond to draft Health Authority guidance documents, ensuring 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 the overall Regulatory landscape per disease.
• Identify opportunities to leverage artificial intelligence and other new tools to simplify business processes; drive implementation and adoption of novel technologies to enhance efficiency and facilitate regulatory intelligence activities.

Requirements

• 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.
• Experience working cross-functionally with diverse stakeholders.
• Experience working in BioPharmaceutical development, including but not limited to, pharmaceutical/biotech industry and government.

Skills

• Solid understanding of the commercial aspects of BioPharmaceutical development.
• In-depth knowledge of the R&I therapeutic area.
• Broad background of experience working in the pharmaceutical business and prior experience in leading competitive intelligence within the pharmaceutical industry or associated industries.
• Critical thinking on current global regulatory science trends and questions with a good understanding of the corresponding scientific and clinical components.
• Previous regulatory policy experience or working with external trade and scientific associations.

Schedule

In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That is why we work, on average, a minimum of three days per week from the office. Balance is respected, with flexibility for individual needs.

Pay

The annual base salary for this position ranges from $186,232 to $279,350 USD. Base pay offered may vary depending on market location, job-related knowledge, skills, and experience. The position also offers a short-term incentive bonus opportunity and eligibility to participate in an equity-based long-term incentive program (for salaried roles) or receive a retirement contribution (for hourly roles).

Benefits

• Qualified retirement program (401(k) plan).
• Paid vacation and holidays.
• Paid leaves.
• Health benefits including medical, prescription drug, dental, and vision coverage, in accordance with the terms and conditions of the applicable plans.