Director, RA Global Regulatory Strategy

Company Description

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. Frequently visit and follow AbbVie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. The role leads the Global Regulatory Product Team (GRPT), expands therapeutic area knowledge, ensures strategic messaging in global regulatory dossiers, may lead the Labeling Regulatory Strategy Team (LRST), and serves as the primary regulatory interface with AST and supporting teams. The Director proactively anticipates and mitigates regulatory risks, ensures compliance with global regulatory requirements, manages compounds through all phases of development including post approval, and demonstrates excellent understanding of drug development and leadership behaviors.

Responsibilities

• Interfaces with the LRST and AST to lead and support cross‑functional company objectives.
• Leads the GRPT to develop creative global strategies aligned with applicable regulations to achieve business objectives for development and marketed products and seeks expert advice and technical support from functional stakeholders when necessary.
• Ensures inclusion of appropriate and clear strategic messaging in global regulatory dossiers and responses to regulatory agency requests.
• Accounts for ensuring that corporate goals are met and acts as the key internal leader and driver of regulatory policy and strategy for assigned products.
• Prepares global regulatory product strategies for assigned products, leads risk assessment and mitigation strategy development, and communicates plans to relevant stakeholders.
• Acts independently under the direction of a GRS Sr GRL or TA Head, may participate or lead regulatory and company initiatives, provides coaching and mentoring to GRPT members, and may have direct reports involved in performance management.
• Influences the development of regulations and guidance by analyzing legislation, regulations, and guidance and providing analysis with worldwide accountability.
• Follows company policies and procedures for regulatory record‑keeping, identifies needs for policy development, and ensures direct reports comply with requirements.
• Ensures alignment of global regulatory strategies with senior management and presents meaningful regulatory assessments and recommendations to executive management.
• Informs AST and cross‑functional management of issues, labeling outcomes, approval or other risks and mitigations, and provides assessment of impact on global programs.
• Represents AbbVie’s regulatory position in interactions at Joint Governance.
• Makes decisions regarding work processes or operational plans and schedules to achieve program objectives established by senior management.
• Advances organizational goals by participating in professional associations, industry, and trade groups as appropriate for assigned projects.
• Follows budget allocations and keeps supervisor informed on project resourcing.
• Chairs or sponsors key GRS initiatives and presents outcomes to the RA leadership team.

Qualifications

• Required Education: Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
• Preferred Education: Relevant advanced degree is preferred. Certification a plus.
• Required Experience: 7+ years regulatory experience; some portion may include pharmaceutical regulatory work such as other R&D roles or specialized training. Requires drug development experience in the US & Canada region, proven 5+ years in a strategic leadership role with strong project management skills, experience working in a complex and matrix environment, and experience interfacing with major government regulatory agencies.
• Required Experience cont’d: Strong communication and proactive negotiation skills, experience developing and implementing successful global regulatory strategies.
• Preferred Experience: 10+ years’ experience in pharmaceutical regulatory activities with experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU or Japan. Strong global drug development foundation with business acumen.
• Note: Higher education may compensate for years of experience.

Additional Information

• 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 the company may ultimately pay more or less than the posted range. The 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.

Note: No amount of pay is considered 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 employer remain in the company’s sole and absolute discretion 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, and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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