Senior Director/Executive Director – Global Regulatory Affairs LATAM

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Senior Director/Executive Director – Global Regulatory Affairs-LATAM

Purpose:

The purpose of the Senior Director/Executive Director, GRA Regional Hub (LATAM) is to provide supervision for most of the affiliate, regulatory and regional GRA professionals in a region as well as Regulatory Alliance support in the framework of Distribution & Promotion Agreements. It is also to provide geographic area regulatory leadership, expertise, and strategy in support of the regional and affiliate regulatory activities. This job must integrate regulatory staffing needs and regulatory activities with other functional areas within the IBU Hub Lead Team(s). In this capacity, this position needs to develop both technical regulatory expertise and a working understanding of the Lilly product portfolio and functional processes. The ability to oversee affiliate and regional regulatory resources and work with corporate and external partners, global regulatory tools, and databases while achieving both business and regulatory objectives are critical for performing this role. The role must be able and willing to travel to visit various affiliates, external partners, drug agencies and academic settings, and must be able to represent Lilly professionally in these settings. Customers include local and regional Medical/Marketing/Business/Quality Management, Regional and Global Regulatory Affairs Management, External Partners and Drug Regulatory Agencies. This role will be based in Brazil and will be part of Brazil’s Lead Team (Board of Directors).

Primary Responsibilities:

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

People:

• Responsible for the supervision and Performance Management (PM) of regional and affiliate Regulatory Affairs personnel.
• Provide feedback and coaching to employees including, objectives-settings, interim and final reviews, development plans and succession plans.
• Develop regional strategies and plans for regulatory professional development including, training programs, Reward and Recognition programs, affiliate, and regional regulatory career path development.
• Oversee recruitment and retention of affiliate and regional regulatory staff.
• Continual assessment of needs and capabilities of affiliate regulatory professionals and direct reports.
• Sponsor regional regulatory meetings, affiliate teleconferences and training events.
• Develop recommendations to regional/affiliate management regarding resource needs and gap analysis.

Regulatory Planning and Business Support:

• Strategic consultant to regional- and affiliate management, regulatory scientists, and regulatory functional support groups on a broad range of regulatory topics and process requirements.
• Active sponsor of the training and management of regulatory tools and associated regulatory business processes.
• Ensure robust regulatory submission strategies for each country in the region, including Alliance Partners, considering local requirements, business priorities and regulatory risks.
• Represent the regulatory function and contribute cross-functionally to ensure timely progress of projects and initiatives in line with regional business priorities and regulatory plans.
• Ensure periodic metrics reports of the regulatory forecast vs. business plan to regional/affiliate management.

Regulatory Compliance:

• Sponsor implementation of Good Regulatory Practices at the regional/affiliate level.
• Strategic consultant to GRA Senior Management and other regulatory functional support groups.
• Regulatory liaison between multiple components (for example, Medical Quality, Global Brand Development Teams, Manufacturing, Sourcing, Medical, Legal, Manufacturing/QA, Area/Country management and Other Regulatory) and regional/affiliate management regarding compliance projects.
• Ensure appropriate risk assessment is in place for all regulatory activities with compliance impact.
• Ensure the availability of proper processes and tools in support of external and internal audits.
• Ensure appropriate usage of regulatory IT tools.

Alliance Management:

• Ensure timely due diligence in collaboration with MQO and develop and maintain Product Registration Agreement (PRA) in collaboration with Legal.
• Enable all aspects of the transition including human resources and product registrations.
• Organize effective Lilly regulatory support structure and ensure strong working relationship with Alliance Partners.
• Monitor partner’s performance, drive escalations to Alliance Management in case of non-compliance and ensure gap-closure strategies are implemented.
• Represent Regulatory Affairs in Alliance Management Meetings.
• Manage internal and external stakeholders' understanding and expectations in supporting the Alliance Partnership.

Regulatory Influence:

• Ensure appropriate engagement with affiliates and external partners to influence the regulatory environment.
• Keep management informed of regulation changes (or potential changes) and any other relevant regulatory intelligence information as appropriate and assess its impact on the business.
• Participate on technical committees in Regional/Global Pharmaceutical Industry Associations, including position paper development in various regional regulatory issues as needed.
• Accurately represent the regulatory environment and emerging trends to cross-functional partners.

Minimum Qualification Requirements:

• Education: BS or Master’s Degree in pharmacy, chemistry, biology, pharmacology or related science or M.D.
• Has acquired managerial skills through experience and training.
• Has acquired technical knowledge across development, manufacturing, and registration.
• Has acquired industry contacts (other companies, organizations) to allow assimilation of industrywide practice and adaptation of best practices at Lilly.
• Has acquired administrative skills to organize projects and get proposals evaluated on a global basis.
• Leadership qualities to allow influence upon policies and procedures internal and external to regulations at Lilly.
• Negotiation skills to allow forward movement of projects.
• Ability to work with multiple projects and handle multiple priorities.

Other Information/Additional Preferences:

• Good knowledge of written and spoken English. Additional languages (spoken in responsibility) of benefit.
• Interpersonal and teamwork skills to allow effective team building across diverse global organizations.
• Focus on detail, accuracy, and organization.
• Familiarity or comfort with cultural diversity.
• Flexible attitude toward frequent changes in strategy or staff.
• Creative thinking and problem-solving skills. Ability to find solutions for complex technical issues.
• Communication skills: verbal, writing, presenting, listening.