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.
May participate in regulatory and Company initiatives.
May influence 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 develop and implement policies and procedures within the RA department.
Under direction from supervisor, makes decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management.
Follows budget allocations and keeps supervisor informed on project resourcing.
Required Education:
Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject).
Preferred Education:
Relevant advanced degree is preferred. Certification a plus
-Required Experience:
Strong communication and proactive negotiation skills. Business acumen and able to work under pressure
Preferred Experience:
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
Benefits
Dental insuranceVision insurance401(k)Paid time off
Additional Information
The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and implementing global regulatory strategies to secure and maintain market approval for product(s) in assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Project responsibilities may include Area Lead (US/Canada) role. May lead the Labeling Regulatory Strategy Team (LRST). Ensures strategic messaging in global regulatory dossiers and responses under guidance of management. May serve as the primary regulatory interface with the AST and supporting teams. 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 strong understanding of drug development and leadership behaviors consistent with level. Develops and implements acceleration strategies with guidance from supervisor.
Abbvie · Boston, MA