AbbVie · 21 hours ago
Director, Oncology Business Development and Global Regulatory Strategy
Florham Park, NJ
Full-time
Onsite
Mid, Senior Level
$177K/yr - $336K/yr
7+ years expAbbVie is dedicated to discovering and delivering innovative medicines and solutions that address serious health issues. The Director, Oncology Business Development and Global Regulatory Strategy is responsible for developing and implementing global strategies for securing market approval of products in oncology, leading cross-functional teams, and ensuring compliance with regulatory requirements.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
Responsibilities
Developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area
Leading the Global Regulatory Product Team (GRPT)
Continually expanding TA knowledge, and ensuring strategic messaging and content of global regulatory dossiers
Leading the Labeling Regulatory Strategy Team (LRST)
Serving as the primary regulatory interface with AST and supporting teams
Proactively anticipating and mitigating regulatory risks
Ensuring compliance with global regulatory requirements
Managing compounds through all phases of development, including post approval and throughout the life cycle of the product
Demonstrating excellent understanding of drug development and leadership behaviors consistent with level
Developing and implementing acceleration strategies
Managing projects and necessary documentation of reg strategies
Leading and supporting cross-functional company objectives
Accountable for ensuring that corporate goals are met
Leading preparation of global regulatory product strategies for assigned products
Proactively leading regulatory and cross-functional team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products
Acting independently under the direction of a GRS Sr GRL or TA Head
Participating in or leading regulatory and Company initiatives
Influencing the development of regulations and guidance
Analyzing legislation, regulations, and guidance and providing analysis to the organization
Following company policies and procedures for regulatory record keeping and developing and implementing policies and procedures within the RA department
Ensuring alignment of global regulatory strategies with Sr. Management
Presenting meaningful regulatory assessments and regulatory recommendations to executive management
Proactively informing AST and cross functional management of issues, labeling outcomes, approval or other risks and mitigations
Providing assessment of impact on global programs
Representing ABBV Regulatory position in interactions at Joint Governance
Making decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management
Advancing the organization’s goals by participating in and taking leadership roles in professional associations, industry, and trade groups as appropriate for assigned projects
Following budget allocations and keeping supervisor informed on project resourcing
Qualification
Required
Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject
7+ years regulatory experience. Some portion may include experience related to pharmaceutical regulatory work (e.g., other R&D role or specialized training). Requires drug development experience in US&Canada region
Proven 5+ years in a strategic leadership role with strong project management skills
Experience working in a complex and matrix environment with multiple stakeholders and influencing cross-functional teams
Experience interfacing with major government regulatory
Strong communication and proactive negotiation skills
Experience developing and implementing successful global regulatory strategies
Preferred
Relevant advanced degree is preferred. Certification a plus
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
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Company
AbbVie
AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.
10001+ employees
H1B Sponsorship
AbbVie has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (273)
2024 (190)
2023 (225)
2022 (284)
2021 (186)
2020 (186)
Funding
Current Stage
Public CompanyTotal Funding
$15B2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO
Leadership Team
Robert Michael
Chairman of the Board and Chief Executive Officer
Micah Bregman
Vice President, Global Strategy and Pipeline, Allergan Aesthetics
Recent News
Pharmaceutical Technology
2026-01-13
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