Head of Global Regulatory Policy & Intelligence

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

The Senior Director (Head of US or Head of ROW), Regulatory Affairs, Regulatory Policy & Intelligence, combines knowledge of the scientific, regulatory and business environment, regarding how medical products and devices are developed, evaluated, authorized and monitored once marketed. Monitors and engages with the external environment for evolving regulations and policies of the Health Authorities (HA) and works closely with Subject Matter Experts (SMEs) to analyze impact and provide insights that inform product development strategy. Establishes, develops and maintains relations with HAs, peer companies, and industry trade associations regarding scientific and regulatory policies. Influences at the division and corporate levels and is considered a key opinion leader for AbbVie. Acts as an advisor/liaison to senior management to plan, evaluate and recommend regulatory strategy. Assists company to comply with scientific, ethical, statutory, quality, and business requirements.

Responsibilities

• Manages and leads global and/or regional topics and staff in the regulatory policy and intelligence function for assigned area (US or ROW). Defines scientific and regulatory policy initiatives. The Head of US is accountable for managing the RPI strategy and tactics for the US market; the Head of ROW is accountable for managing the RPI strategy and tactics for all other regions. Both positions are accountable for partnering closely with each other to ensure global topics are coordinated and ma
• As policy subject expert, analyzes proposed policies and distributes to SMEs. Coordinates internal review. Leads formation of corporate position to share with trade associations.
• Manages and mentors junior staff in approaches to complex policy issues.
• Prepares and presents complex written and oral reports to Senior Management and external audiences on scientific and regulatory topics.
• Proposes sound regulatory policies influencing the regulatory environment in one or more geographic regions based on in depth scientific knowledge of topic and by working closely with SMEs.
• Directs staff to identify and influence policies that impact AbbVie. Effectively uses negotiation skills to resolve policy issues when unable to agree internally. Anticipates consequences of path chosen.
• Serves as primary liaison to trade associations for management on scientific and regulatory issues.
• Supports supervisor and Senior Management in discussions of complex policy topics at trade associations.
• Contributes to regulatory product development by responding to requests for information and providing an analysis of the regulatory environment. May offer alternative views based on regulatory knowledge and prior experience.
• Conducts external outreach with regulators, peers, and trades. Creates and responds to opportunities to enhance AbbVie’s relationship by organizing, speaking at, and participating in policy-related meetings. Utilizes network of local pharma companies to obtain policy-related information.

• Required Education: Bachelor’s degree related to health, environment, or politics. Degrees in Pharmacy, Chemistry, Biology, Pharmacology, Law or Policy are most relevant.
• Preferred Education: Relevant Master’s degree in a scientific, health, legal, or business discipline. Regulatory certifications a plus
• Required Experience: 12+ years in regulated industry or health authority. Policy and drug development experience is most relevant.
• Experience working in a complex and matrix environment. Experience working cross functionally to reach consensus. Strong negotiation skills.
• Strong communication skills, both oral and written. Fluency in other languages is needed for regional assignments.
• Preferred Experience: 10+ years of relevant area experience in pharmaceutical or other healthcare industry with some regulatory policy and intelligence experience. 5 years of relevant pharmaceutical experience in quality assurance, research and development, scientific affairs, and operations. Proven 7+years in a leadership role with strong management skills.
• Knowledge of global healthcare regulations in support of drug development
  Note: Higher education may compensate for years of experience

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 thisposting 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 anduntil 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 and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

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

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