Sr. Director – Global Regulatory Lead

Purpose:

The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to developand implementinnovative global regulatory strategies for product(s) in the assigned therapeutic area.  The GRLis the accountable decision maker for the development & execution of global regulatory strategiesfrom portfolio entry to end of life cycle to ensure strategies meet global business objectivesand regional/local affiliate requirements.

The GRL creates and leads the Global Regulatory Team (inclusive of GRA central functions, GRA-CMC,GRA-Devices, and regional regulatory scientists)and is responsible for forming and maintaining ahighly effective global regulatory team. The GRL is responsible for the creation and maintenance of the Regulatory Strategy Document (RSD) and ensures local plans, created by the regional regulatory teams, are aligned to the Global Brand Development (GBD)/global program team and business priorities in terms of the program’s value proposition, workflow, product labeling, risk management, and issues management.Accordingly, the GRL is the primary interface with and will represent GRA on GBD/global program team to ensure global input into development plans, provide solutions (created with the regulatory team) to development and regulatory barriers, and reflect and manage risks.  The GRL will represent regional regulatory plans to the GBD/global program team and at stakeholder/governance meetings and is responsible to include GRA functional and regional expertsas 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 will be the responsibility of the regional regulatory scientists.

Primary Responsibilities:

Regulatory and Scientific Expertise

Develop, Update and Execute the Global Regulatory Strategy - Initiate and Update Regulatory Strategy Document (RSD)

• Obtain input from the global regulatory team members to develop a global regulatory strategy which supports product (including delivery device and relevant medical devices) development, registration, and lifecycle maintenance globally. Ensure regulatory strategy is integrated into the development team plan from Candidate Selection to End of Product Lifecyle (including NILEX).  Develop and implement innovative approaches and solutions, and drive acceleration strategies.  Identify and effectively communicate regulatory risks.

• Lead Global Regulatory Team in the development of RSD(s) for assigned programs.  Initiate andmaintainregulatorystrategydocuments byleveragingteam expertise, as well as scientific, drug/device clinical development and knowledgefromhealth authorities such as regulatory policies, regulatory precedents, trends, and emerging regulatory science.Integrateinformationfromthe externalenvironment,productspecificregulatoradvice,andotherpublicinformation(i.e.AdvisoryCommittees) to developrobust, innovativeregulatorystrategies and solutions.

• Provide input for and attend key regulatory agency meetings, as needed, that could impact the global product strategy or brand. 

• Enable discussion of the RSD and regulatory issues/challenges at the Regulatory Strategy Forum together with Global Regulatory Team.

• Continually expand therapeutic area knowledge. Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment.Monitor upcomingand recentapprovalsof competitive developmentprograms/plans.

• Ensure strategic messaging and content of global regulatory submission documents. Provide regulatory direction in the development of the core data sheet and claims mapping to align commercial objectives in the context of available and expected scientific data, regulatory guidance, and precedent.

• Ensures local strategies and solution deliver to the global regulatory strategy and meets business and brandgoals.

• Provide timely and effective communication updates to the GBD teams and business management and other internal stakeholders, as appropriate.

Lead Global Regulatory Team

• Lead Global Regulatory Team consisting of regional regulatory scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and GRA-Global Labeling and Product Communications. Ensures clear and transparent two-way communication between GBD/global program team and Global Regulatory Team.

• Coach and facilitate a feedback culture within the Global Regulatory Team to develop team performance.

• Communicate and share key information to enable seamless execution of global regulatory strategy and cross-functional shared learnings.

Represent Regulatory on the GBD/Global Program Team

• Support development teams in strategic planning, trial design and registration strategies for all in-scope countries for assigned products/programs, bringing in regional, CMC and Device regulatory scientists as needed.

• Consistently communicate well defined, successful regulatory strategies throughout the organization.

For Preclinical and Early Clinical Development Programs: Lead and develop the US and Canada strategy for submission and amendments for IND, IDE, CTA

• Determineand communicatesubmission andapprovalrequirements and regulator expectations.

• Generateregulatorydocumentsand ensuretheregulatorydocumentscontainappropriatedata/information based on regulator expectations andare clearly written toarticulateLilly’s scientific position.

• Anticipate, resolve, and communicatekeytechnical,operational,andstrategicissuesthat mayimpactother development functionsor thedevelopmentteam.

• Propose innovative solutions to regulatory issues to meet the business objectives while maintaining compliance with applicable regulations and internal quality systems.

• Own relationship and interaction strategy with US and Canada regulatory authorities.

• Build,maintain,andleveragerelationshipswithFDA, Health Canada, team members, andpartner companiesasappropriate.

• ExecutehighqualitycommunicationswithFDA, Health Canada,and internalcustomersto articulate and ensure understanding of theregulatorystrategyand complexissues.

• Accountableforcommunicationsto theregulator,developmentteams,GRA, other development functions, Research, and BU leadership.

Engage in, influence, and shape external environment initiatives related to portfolio assets

• Creates and fosters strategic relationship with key external players to identify and anticipate opportunities for growth.

Review corporate communications press releases

• Set appropriatedirection with Global Marketing and GBD teamfordevelopment, review, and approval of promotional claims.

• Partner with Regulatory Product Communications reviewer to advise GBD team on promotional strategy.

• Partner with Regulatory Product Communications reviewer to review and approve press materials and IR communications.

Lead/Influence/Partner

• Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, and Deliver in internal and external interactions.

• Model the innovation, leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers.

• Constructivelychallengeteams to reachthebest solutions toissues.

• Serve as a mentor for GRA personnel.

• May have direct reports.

Minimum Qualification Requirements:

• Advanced scientific degree (i.e., PhD, PharmD) and 8+ years Industry-related experience in regulatory affairs and/or drug development experience

OR

• Bachelor’s degree with 10+ years of industry-related experience in regulatory affairs and/or drug development experience

Other Information/Additional Preferences: