Director, RA Regulatory Policy & Intelligence

About the role

The Director, Regulatory Affairs, U.S. Regulatory Policy & Intelligence (RPI), supports and guides product development strategy by utilizing knowledge of the scientific, regulatory, and business environment regarding medicinal products and medical devices. They also establish and maintain strategic relationships with internal and external partners to shape US and ICH scientific and regulatory policy.

Responsibilities

• Independently manages and leads U.S. regulatory policy and intelligence activities, defining scientific and regulatory policy initiatives that advance company priorities.
• Serves as the subject matter expert for CMC, product quality, pharmaceutical quality systems, and supply chain management policy; analyzes proposed regulations and distributes impact assessments to key internal stakeholders and senior management within various functional areas.
• Contributes to the regulatory product strategy that is developed by the Global Regulatory Leads and Regulatory leadership.
• Establishes and cultivates strategic relationships with internal and external partners; identifies and acts on opportunities to strengthen AbbVie's standing through active participation in policy-related forums and industry networks.
• Research, authors, and presents briefings, policy positions, and high-level communications to senior management with clarity and strategic focus.
• Identifies through partnerships and internal subject matter experts, regulatory policy priorities for assigned topics or therapeutic area(s) and coordinates communication of final policy intelligence to support the implementation of new regulatory policy and guidance across AbbVie functions.
• Engages cross-functional teams to develop strategic/long-term plans for the development and implementation of policies.
• Manages AbbVie's regulatory policy commenting process, applying knowledge of FDA precedents and procedures to produce influential submissions that advance AbbVie's policy positions.
• Actively engages to shape the US & ICH scientific and regulatory policy in the regulatory CMC, product quality and supply chain management space, partnering with cross-functional experts, and leading regulatory advocacy through trade associations, external organizations, and guidance consultations.
• Identifies US and scientific policy trends in the CMC, product quality and supply chain management space that could impact development programs, compliance, and assurance of product supply to patients.

Requirements

• Bachelor's degree or higher in a scientific discipline required; advanced degree in public policy, life sciences, law, or a related field preferred.
• 12+ years of relevant experience required, including a minimum of 5+ years in regulatory policy and intelligence; 4+ years of relevant experience at the U.S. FDA in a regulatory CMC or policy role (e.g., OPQ, OPPQ) preferred.
• Deep knowledge of healthcare regulations, the drug development lifecycle, and FDA/ICH requirements governing CMC, quality systems, inspections, and supply chain; proven track record of shaping policy agendas and leading advocacy strategies in this space.
• Demonstrated ability to operate effectively within complex, matrixed, and multinational environments.
• Excellent verbal, written, and presentation communication skills, with the ability to translate complex and evolving legislation and regulations into clear, actionable insights for internal and external stakeholders.
• Strong strategic thinking and execution capabilities.
• Proven track record of engaging key thought leaders and diverse stakeholders; ability to thrive in a fast-paced, matrixed, multinational environment.
• Demonstrated success advising senior CMC, quality, and supply chain functional leadership, with a proven ability to influence and align senior stakeholders across multiple functions.

Qualifications

• Experience in pharmaceutical or other healthcare industry with some regulatory policy and intelligence experience, preferably including experience with trade associations.
• Experience in quality assurance, research and development, scientific affairs, and operations.
• Leadership experience with strong managerial and research skills.

Skills

• Strategic thinking and execution.
• Effective communication and presentation skills.
• Ability to engage key stakeholders and thought leaders.
• Experience in regulatory policy and intelligence.
• Knowledge of healthcare regulations and drug development lifecycle.
• Experience with FDA/ICH requirements and policies.

Benefits

Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k).

Pay

$182,000 - $346,000 USD

Schedule

Hybrid

Location

Rockville, MD

Requisition Number

N/A