Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Director, Regulatory Affairs, 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 and works closely with Subject Matter Experts (SMEs) to analyze impact and plan strategy accordingly. Establishes, develops, and maintains relations with HAs and peer companies, industry trade associations 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. May supervise others.

• Independently manages and leads global and/or regional topics in the regulatory policy and intelligence function. Defines scientific and regulatory policy initiatives supporting company priorities.
• Serves as policy subject expert based on in depth knowledge of key regulatory and scientific issues. Analyzes proposed policies and distributes to SMEs.
• Contributes to regulatory product development strategy by responding to information requests from product teams or senior management and providing an analysis of the regulatory environment. May offer alternative views based on regulatory knowledge and prior experience.
• Ability to establish strategic relationships with internal and external customers and partners. Creates and responds to opportunities to enhance AbbVie’s relationship by participating in policy-related meetings. Utilizes local network of pharma companies to obtain policy-related information.
• Demonstrated strong written, spoken and presentation communication with ability to research, write briefings, policy positions and high-level communications, and demonstrated ability to present key messages to Senior Management
• Demonstrated leadership skills and effectiveness in the areas of influence, team leadership, articulating and taking a position, negotiation, and conflict resolution.
• Identifies regulatory policy priorities for assigned topics or therapeutic area 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​.
• Leads policy activities at national, regional, or global level and manages AbbVie's global regulatory policy commenting process and staff providing knowledge of FDA/US policy precedents and process to deliver influential commenting deliverables to advance AbbVie's policy positions.​

Qualifications

Required Experience:

• Bachelor’s degree or higher in a scientific related discipline required. 12+ years relevant experience required, with 5+ years in regulatory policy and intelligence experience preferred.
• Ability to work within a complex and matrix environment.
• Strong communication and negotiation skills, both oral and written. Fluency in other languages is needed for specific regional assignments.

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.
• Knowledge of healthcare regulations in support of drug development.
• Proven 3+years in a leadership role with strong managerial and research skills.
• 4+ years relevant work experience at a government health authority preferred.

Additional Information

Applicable 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 short-term incentive programs. ​

• 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.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html