Allergan Aesthetics, an AbbVie Company · 1 day ago
Director, RA Global Regulatory Strategy
North Chicago, IL, USA
Full-time
Hybrid
Director/Executive
$177K/yr - $336K/yr
7+ years expAllergan Aesthetics, an AbbVie Company, is focused on delivering innovative medicines and solutions in the pharmaceutical industry. The Director Regulatory Affairs is responsible for developing and implementing global regulatory strategies to secure market approval for products, leading cross-functional teams, and ensuring compliance with regulatory requirements.
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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 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)
Short-term incentive programs
Company
Allergan Aesthetics, an AbbVie Company
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Nicole Mowad-Nassar
Senior Vice President, AbbVie and President, Global Allergan Aesthetics
Recent News
2025-12-04
Company data provided by crunchbase