Job DescriptionThe Director, Regulatory Affairs, U.S. Regulatory Policy & Intelligence (RPI), utilizes knowledge of the scientific, regulatory, and business environment regarding how medicinal products and medical devices are developed, evaluated, authorized and monitored once marketed to support and guide product development strategy. Develops and maintains strong partnerships with regional area and affiliate staff that interact with Health Authorities (HAs). Monitors external environment for evolving policies that impact product development, lifecycle maintenance and on-market support working closely with Subject Matter Experts (SMEs) to analyze impact. Establishes, develops, and maintains relations with HAs and peer companies, industry trade associations, and external organizations regarding scientific and regulatory policies. Leads cross-functional, multidisciplinary teams, to comment to HAs. Through knowledge gained, assists company to comply with scientific, ethical, statutory, quality, and business requirements. Works independently, requires minimal supervision, assumes project responsibility, and interacts with senior management.
- 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
QualificationsRequired Experience:- 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.
Preferred Experience:
- 5+ years in relevant area experience in pharmaceutical or other healthcare industry with some regulatory policy and intelligence experience, preferably including experience with trade associations.
- 3+ years of relevant pharmaceutical experience in quality assurance, research and development, scientific affairs, and operations.
- Proven 3+years in a leadership role with strong managerial and research skills.
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
