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Director, Global Regulatory Lead - Boston, United States - AbbVie
Description
Job DescriptionAll potential applicants are encouraged to scroll through and read the complete job description before applying.
The Director, Global Regulatory Lead, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area.
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.
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 membersInfluences 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.
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 GovernanceMakes 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.Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
