AbbVie · 1 day ago
Director, RA Global Regulatory Strategy
Florham Park, NJ
Full-time
Hybrid
Mid, Senior Level
$177K/yr - $336K/yr
7+ years expAbbVie is dedicated to discovering and delivering innovative medicines that address serious health issues. The Director of Regulatory Affairs Global Regulatory Strategy is responsible for developing and implementing global strategies to secure market approval for products in the obesity/metabolic therapeutic area, leading cross-functional teams, and ensuring compliance with global regulatory requirements.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
Responsibilities
Interfaces with the LRST and AST to lead and support cross-functional company objectives
Leads the GRPT to development of creative global strategies in line with applicable regulations to achieve business objectives for development and marketed products
When necessary, seeks expert advice and technical support from functional stakeholders, supervisor, and TAH level personnel
Leads cross-functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory Agency requests
Accountable for ensuring that corporate goals are met
Key internal leader and driver of regulatory policy and strategy for assigned products
Leads preparation of global regulatory product strategies for assigned products
Proactively leads regulatory and cross-functional team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products and communicates plan to relevant stakeholders
Acts independently under the direction of a GRS Sr GRL or TA Head
May participate in or lead regulatory and company initiatives
Based on experience and scientific strengths, expands knowledge of TA and provides coaching and mentoring for GRPT members
May have direct report(s) and contribute to the performance management for other RA team members
Influences the development of regulations and guidance
Analyzes legislation, regulations, and guidance and provides analysis to the organization, with worldwide accountability for assigned products
Follows company policies and procedures for regulatory record keeping and may identify need for and develop and implement policies and procedures within the RA department and, if applicable, ensure direct reports follow requirements
Ensures alignment of global regulatory strategies with Sr. Management
Under minimal guidance of supervisor, presents meaningful regulatory assessments and regulatory recommendations to executive management
Proactively informs AST and cross functional management, including RDLT and Commercial Leadership of issues, labeling outcomes, approval or other risks and mitigations
Provides assessment of impact on global programs
Represents ABBV Regulatory position in interactions at Joint Governance
Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management
Advances the organization’s goals by participating in and taking leadership roles in professional associations, industry, and trade groups as appropriate for assigned projects
Follows budget allocations and keeps supervisor informed on project resourcing (headcount-related fees, filing fees, and professional services)
Chairs or sponsor key GRS initiatives and presents outcomes to RA LT
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&C region
Proven 5+ years in 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 bodies
Strong communication and proactive negotiation skills
Experience development and implementing successful global regulatory strategies
Preferred
Relevant advance 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 development foundation with business acumen
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs
Long-term incentive programs
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
2026-01-06
BioWorld Financial Watch
2026-01-04
Company data provided by crunchbase