Director, RA Global Regulatory Strategy
About The Position
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. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle of the product. Demonstrates excellent understanding of drug development and leadership behaviors consistent with level. Develops and implements acceleration strategies. Manages projects and necessary documentation of reg strategies.
Requirements
- 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).
- 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 agencies.
- Strong communication and proactive negotiation skills.
- Experience developing and implementing successful global regulatory strategies.
Nice To Haves
- 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.
- Higher education may compensate for years of experience.
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.
- Seeks expert advice and technical support from functional stakeholders, supervisor, and TAH level personnel when necessary.
- 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.
- Expands knowledge of TA and provides coaching and mentoring for GRPT members based on experience and scientific strengths.
- 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.
- 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.
- Presents meaningful regulatory assessments and regulatory recommendations to executive management under minimal guidance of supervisor.
- 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 sponsors key GRS initiatives and presents outcomes to RA LT.
Benefits
- paid time off (vacation, holidays, sick)
- medical/dental/vision insurance
- 401(k)
- long-term incentive programs
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What This Job Offers
Job Type
Full-time
Career Level
Director
