BioSpace
Sr. Director - Global Regulatory Lead - Neuroscience/Immunology
BioSpace, Indianapolis, Indiana, us, 46262
Sr. Director - Global Regulatory Lead - Neuroscience/Immunology
Lilly is a global healthcare leader focused on discovering and bringing life-changing medicines to patients. We aim to improve understanding and management of disease and support communities through philanthropy and volunteerism. We are seeking a Senior Director, Global Regulatory Affairs, Global Regulatory Lead (GRL) to develop and implement innovative global regulatory strategies for products in the assigned therapeutic area. The GRL is the accountable decision maker for the development and execution of global regulatory strategies from portfolio entry to end of life cycle to ensure strategies meet global business objectives and regional/local affiliate requirements. The GRL creates and leads the Global Regulatory Team (including GRA central functions, GRA-CMC, GRA-Devices, and regional regulatory scientists) and is responsible for forming and maintaining a highly effective global regulatory team. The GRL develops and maintains the Regulatory Strategy Document (RSD) and ensures local plans, created by regional regulatory teams, align with the Global Brand Development (GBD)/global program team and business priorities in terms of program value proposition, workflow, product labeling, risk management, and issues management. The GRL represents GRA on the GBD/global program team to provide global input into development plans, address regulatory barriers, and reflect and manage risks. The GRL represents regional regulatory plans to the GBD/global program team and attends stakeholder/governance meetings, including GRA experts as needed to inform development and manage issues. For preclinical and early clinical development programs, the GRL leads the US and Canada submissions and agency interactions; all other agency interactions are the responsibility of regional regulatory scientists. Primary Responsibilities
Regulatory and Scientific Expertise
Develop, update and execute the Global Regulatory Strategy and initiate/update the Regulatory Strategy Document (RSD). Obtain input from the global regulatory team to develop a global regulatory strategy that supports product development, registration, and lifecycle maintenance globally, including devices where applicable. Integrate regulatory strategy into the development team plan from candidate selection to end of product lifecycle. Develop and implement innovative approaches and acceleration strategies; identify and communicate regulatory risks. Lead Global Regulatory Team in developing RSDs for assigned programs, leveraging team expertise and external regulatory precedents and guidance. Provide input for and attend key regulatory agency meetings as needed that could impact global product strategy or brand. Facilitate discussion of the RSD and regulatory issues at the Regulatory Strategy Forum with the Global Regulatory Team. Continuously expand therapeutic area knowledge and monitor impact of global regulations and guidelines; monitor approvals of competitive programs. Ensure strategic messaging and content of global regulatory submission documents; guide core data sheet development and claims mapping to align with commercial objectives and regulatory expectations. Ensure local strategies align with global regulatory strategy and meet business/brand goals; provide timely updates to GBD teams and stakeholders.
Lead Global Regulatory Team
Lead a team including regional regulatory scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and GRA-Global Labeling and Product Communications; ensure clear two-way communication between GBD/global program team and the Global Regulatory Team. Coach and foster a feedback culture to improve team performance; share information to enable seamless execution of strategy and cross-functional learning.
Represent Regulatory on the GBD/Global Program Team
Support development teams in strategic planning, trial design, and registration strategies for all in-scope countries, bringing in regional, CMC and Device regulators as needed; communicate well-defined regulatory strategies organization-wide.
For Preclinical and Early Clinical Development Programs
Lead US and Canada strategy for IND/IDE/CTA submissions and amendments; determine and communicate submission and regulator expectations. Generate regulatory documents with appropriate data to satisfy regulator expectations and articulate Lilly’s scientific position. Anticipate and resolve issues that impact other development functions; propose innovative regulatory solutions to meet business objectives while maintaining compliance. Own relationship and interaction strategy with US and Canada regulatory authorities; build and maintain relationships with FDA, Health Canada, team members, and partners as appropriate; communicate regulatory strategy and complex issues to regulators and internal customers. Engage in, influence and shape external environment initiatives
Foster strategic relationships with key external partners to identify opportunities for growth.
Other Responsibilities
Set appropriate direction with Global Marketing and GBD for development, review, and approval of promotional claims; collaborate with Regulatory Product Communications reviewers on promotional strategy and press materials. Lead/Influence/Partner: exemplify Lilly values, mentor GRA personnel, and encourage a culture of innovation, leadership, and regulatory excellence. May have direct reports. Minimum Qualification Requirements
Advanced scientific degree (PhD, PharmD) and 8+ years of industry-related experience in regulatory affairs and/or drug development, or Bachelor’s degree with 10+ years of industry-related regulatory affairs and/or drug development experience Other Information/Additional Preferences
Proven leadership with bold, effective communication and conflict management skills; knowledge of global regulatory procedures and reform initiatives is desirable. Deep knowledge of the integrated drug development process and Lilly’s or external peers’ regulatory/business strategies. Ability to collaborate across diverse teams and manage risk in a highly regulated environment; strong written, spoken, and presentation communication; negotiation and influence skills; attention to detail. Travel 10-15%; experience in regulatory submissions/interactions in US, EU, China, and Japan; previous leadership roles across multiple countries; experience in neuroscience and/or immunology. EEO Statement: Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce and provides accommodation requests for submitting resumes. Lilly is an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Compensation will depend on education, experience, skills, and location. The anticipated wage range is $162,000 - $237,600 with eligibility for a company bonus and comprehensive benefits. Lilly reserves the right to amend compensation and benefit programs at its discretion. #WeAreLilly
#J-18808-Ljbffr
Lilly is a global healthcare leader focused on discovering and bringing life-changing medicines to patients. We aim to improve understanding and management of disease and support communities through philanthropy and volunteerism. We are seeking a Senior Director, Global Regulatory Affairs, Global Regulatory Lead (GRL) to develop and implement innovative global regulatory strategies for products in the assigned therapeutic area. The GRL is the accountable decision maker for the development and execution of global regulatory strategies from portfolio entry to end of life cycle to ensure strategies meet global business objectives and regional/local affiliate requirements. The GRL creates and leads the Global Regulatory Team (including GRA central functions, GRA-CMC, GRA-Devices, and regional regulatory scientists) and is responsible for forming and maintaining a highly effective global regulatory team. The GRL develops and maintains the Regulatory Strategy Document (RSD) and ensures local plans, created by regional regulatory teams, align with the Global Brand Development (GBD)/global program team and business priorities in terms of program value proposition, workflow, product labeling, risk management, and issues management. The GRL represents GRA on the GBD/global program team to provide global input into development plans, address regulatory barriers, and reflect and manage risks. The GRL represents regional regulatory plans to the GBD/global program team and attends stakeholder/governance meetings, including GRA experts as needed to inform development and manage issues. For preclinical and early clinical development programs, the GRL leads the US and Canada submissions and agency interactions; all other agency interactions are the responsibility of regional regulatory scientists. Primary Responsibilities
Regulatory and Scientific Expertise
Develop, update and execute the Global Regulatory Strategy and initiate/update the Regulatory Strategy Document (RSD). Obtain input from the global regulatory team to develop a global regulatory strategy that supports product development, registration, and lifecycle maintenance globally, including devices where applicable. Integrate regulatory strategy into the development team plan from candidate selection to end of product lifecycle. Develop and implement innovative approaches and acceleration strategies; identify and communicate regulatory risks. Lead Global Regulatory Team in developing RSDs for assigned programs, leveraging team expertise and external regulatory precedents and guidance. Provide input for and attend key regulatory agency meetings as needed that could impact global product strategy or brand. Facilitate discussion of the RSD and regulatory issues at the Regulatory Strategy Forum with the Global Regulatory Team. Continuously expand therapeutic area knowledge and monitor impact of global regulations and guidelines; monitor approvals of competitive programs. Ensure strategic messaging and content of global regulatory submission documents; guide core data sheet development and claims mapping to align with commercial objectives and regulatory expectations. Ensure local strategies align with global regulatory strategy and meet business/brand goals; provide timely updates to GBD teams and stakeholders.
Lead Global Regulatory Team
Lead a team including regional regulatory scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and GRA-Global Labeling and Product Communications; ensure clear two-way communication between GBD/global program team and the Global Regulatory Team. Coach and foster a feedback culture to improve team performance; share information to enable seamless execution of strategy and cross-functional learning.
Represent Regulatory on the GBD/Global Program Team
Support development teams in strategic planning, trial design, and registration strategies for all in-scope countries, bringing in regional, CMC and Device regulators as needed; communicate well-defined regulatory strategies organization-wide.
For Preclinical and Early Clinical Development Programs
Lead US and Canada strategy for IND/IDE/CTA submissions and amendments; determine and communicate submission and regulator expectations. Generate regulatory documents with appropriate data to satisfy regulator expectations and articulate Lilly’s scientific position. Anticipate and resolve issues that impact other development functions; propose innovative regulatory solutions to meet business objectives while maintaining compliance. Own relationship and interaction strategy with US and Canada regulatory authorities; build and maintain relationships with FDA, Health Canada, team members, and partners as appropriate; communicate regulatory strategy and complex issues to regulators and internal customers. Engage in, influence and shape external environment initiatives
Foster strategic relationships with key external partners to identify opportunities for growth.
Other Responsibilities
Set appropriate direction with Global Marketing and GBD for development, review, and approval of promotional claims; collaborate with Regulatory Product Communications reviewers on promotional strategy and press materials. Lead/Influence/Partner: exemplify Lilly values, mentor GRA personnel, and encourage a culture of innovation, leadership, and regulatory excellence. May have direct reports. Minimum Qualification Requirements
Advanced scientific degree (PhD, PharmD) and 8+ years of industry-related experience in regulatory affairs and/or drug development, or Bachelor’s degree with 10+ years of industry-related regulatory affairs and/or drug development experience Other Information/Additional Preferences
Proven leadership with bold, effective communication and conflict management skills; knowledge of global regulatory procedures and reform initiatives is desirable. Deep knowledge of the integrated drug development process and Lilly’s or external peers’ regulatory/business strategies. Ability to collaborate across diverse teams and manage risk in a highly regulated environment; strong written, spoken, and presentation communication; negotiation and influence skills; attention to detail. Travel 10-15%; experience in regulatory submissions/interactions in US, EU, China, and Japan; previous leadership roles across multiple countries; experience in neuroscience and/or immunology. EEO Statement: Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce and provides accommodation requests for submitting resumes. Lilly is an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Compensation will depend on education, experience, skills, and location. The anticipated wage range is $162,000 - $237,600 with eligibility for a company bonus and comprehensive benefits. Lilly reserves the right to amend compensation and benefit programs at its discretion. #WeAreLilly
#J-18808-Ljbffr