The Director, Regulatory Affairs - Global Regulatory Lead, is responsible for developing and implementing US/ Canada and global regulatory strategies to secure and maintain market approval in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT), expands TA knowledge, and manages strategic messaging and content of US, Canada and global regulatory dossiers. Serves as the primary regulatory interface with the GBT and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Demonstrates understanding of drug development and leadership behaviors consistent with level. Develops and implements acceleration strategies. Ensures alignment of global regulatory strategies with Sr. management.
Leads a team of global regulatory professionals for development and marketed products. Accountable for ensuring that corporate goals are met. Manages the content of global regulatory dossiers. Key internal leader and driver of regulatory policy and strategy for assigned products. Leads preparation of global, US and Canadian regulatory product strategies for assigned products. Leads regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products. Ensures the key deliverables for the role: regulatory support of clinical development for new indications, overall regulatory strategy for manufacturing initiatives and management of label updates Acts independently under the direction of a GPS Platform/ Cluster Lead. May participate in or lead initiatives. Based on experience and scientific strengths, expands TA knowledge of TA; provides coaching and mentoring for GRPT members. Influences the development of regulations and guidance. Advises management of the effect of current or proposed laws, regulations, guidelines and standards, etc. Ensures alignment of global regulatory strategies with Sr. Management. Proactively informs GBT and management of issues, risks and mitigations. Provides assessment of impact on global, US and Canadian programs. Provides informed regulatory opinion based on experience and expertise. Works with GRPT to develop, communicate goals that are in alignment with the business goals. Communicates to regulatory team and cross-functionally the immediate to long-range plans to carry out objectives established by senior management. Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management. Advances the organization's goals by participating and taking leadership roles in professional associations, industry and trade groups as appropriate for assigned projects.
Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject required; Relevant advanced degree is preferred. Certification a plus
- 10+ 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 3 years in a leadership role.
- Experience in a broad scope of functions, including CMC and clinical operations and/or project management is strongly desirable
- Experience working in a complex and matrix environment with multiple stakeholders and on cross-functional teams
- Strong communication and proactive negotiation skills. Experience contributing to enterprise management of a portfolio of products
- Experience interfacing with government regulatory agencies. Experience developing and implementing successful global regulatory strategies
- Experience as lead regulatory product strategist in two or more major regions such as EU or Japan preferred
- Ability to travel 10-20% of the time including US and International travel.
RELATIONSHIP WITH OTHERS:
Reports to Senior Director, Cluster Lead, Regulatory Affairs; represents Department and overall organization as lead contact within internal and external corporate and regulatory environs.