Director, Sr Director, Executive Director of Global Regulatory Affairs Chemistry, Manufacturing & Controls and Devices-LATAMCanada

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. Were looking for people who are determined to make life better for people around the world.

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. Were looking for people who are determined to make life better for people around the world.

Purpose:

The purpose of the Director Sr Director Executive Director of Global Regulatory Affairs Chemistry Manufacturing & Controls and Devices-LATAM/Canada (GRA-CMCD-LATAM/Canada) is to provide strategic tactical and operational direction to expedite CMC development of Lillys portfolio and to develop successful regulatory strategies to support market registrations and product lifecycle maintenance in LATAM/Canada region including markets such as Canada Brazil Mexico Argentina Columbia Chile Peru Ecuador Panama Costa Rica The Caribbean etc. This is accomplished with a strong working knowledge of global and LATAM/Canada-regional regulations guidelines and regulatory precedence coupled with a strong technical knowledge of development and manufacturing processes. To accomplish this purpose it is necessary for the scientist to develop collegial and mutually productive relationships across Lilly components partner with broader GRA-CMCD GRA regional teams and regional affiliates Manufacturing and Quality (M&Q) and Product Research & Development (PR&D). This role is further accomplished by developing mutually productive relationships with regional regulatory agencies such as ANVISA (Brazil) and COFEPRIS (Mexico) to shape regional CMC regulatory environments and influence regional regulatory frameworks.

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 supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Regulatory & Scientific Expertise

• Deep technical knowledge and understanding of CMC molecule drug development drug substance and drug product manufacturing manufacturing quality systems and compliance expectations.
• Recognized internally and externally as an expert having a broad technical knowledge of global CMC regulatory requirements and guidelines for registrations in LATAM/Canada region.
• Utilizes specialized regulatory expertise to develop and lead implementation of new regulatory practices based on changes in the external environment.
• Makes technical decisions on CMC regulatory issues that set new standards impacting registrations across multiple programs and geographies.
• Independently networks and gains alignment with upper Business Units legal M&Q and/or GRA management to resolve complex issues.
• Provide high quality timely and decisive regulatory advice to allow project teams to make well-informed decisions on development or product lifecycle planning.
• Anticipates and resolves key technical or operational issues that can impact the function CMC team and/or LATAM/Canada-region submission timing.
• Reviews and approves CMC documents for product registrations in LATAM/Canada region and networks with GRA-CMCD to assess impact of submissions for manufacturing changes new products or line extensions.
• Independently manages risky (that is technically challenging political) problems and identifies creative and/or alternative solutions that support GRA-CMCD-LATAM/Canada objectives and partner requirements.

Influence

• Networks independently with leadership teams in GRA GRA-CMCD including GRA-International Operations PR&D and M&Q building awareness and alignment on complex CMC regulatory strategies.
• Makes technical decisions on CMC regulatory issues that set new company standards for future product development and registrations across LATAM/Canada region.
• Recognized as model of strong leadership behaviors and provides mentoring to affiliates GRA-CMCD M&Q and GRA Regulatory Delivery & Excellence (RD&E) staff on technical and/or regulatory topics.
• Leads strategic initiatives to incorporate new regulations guidance and company positions into Lilly processes/guidelines tools and/or training materials while building in efficiency.
• Influences policy and emerging regulations in LATAM/Canada region for CMC issues (internally and externally).
• Leads initiatives within industry organizations effectively increasing Lillys visibility and influence of evolving regulatory positions.

Leadership Collaboration and Partnering

• Independently develops complex LATAM/Canada-regional CMC regulatory strategies and networks for alignment across PR&D M&Q GRA and regional affiliates as required to enable timely completion of LATAM/Canada-regional submission milestones.
• Partners with GRA and regional affiliates to pursue fast as possible regulatory pathways.
• Takes a proactive leadership role and coordinates with LATAM/Canada-regional colleagues in the critical review of CMC development strategies and submission content for global and LATAM/Canada-region registrations and response-to-query submissions.
• Proactively identifies and resolves LATAM/Canada-regional CMC regulatory issues leveraging internal experts to develop complex regulatory strategies.
• Communicates effectively to lead and influence across GRA GRA-CMCD M&Q RDE and affiliates at the junior management and peer levels within work group/function and with project team.
• Participates and leads forums that share LATAM/Canada-regional regulatory information across Lilly.
• Leads efforts for the development of corporate positions on and responses to proposed agency regulations and guidelines in the LATAM/Canada region.

Minimum Qualification Requirements:

• Minimum a college degree (BSc) ideally an advanced degree (MSc PhD PharmD preferred) in related biological and life science field (e.g. chemistry biology biochemistry or pharmacy)
• 7-10 years pharmaceutical industry experience in technical drug development and/or medical device

Other Information/Additional Preferences:

• Pharmaceutical industry experience in a manufacturing environment e.g. Manufacturing Sciences and Technology Quality Assurance Analytical Laboratories or Manufacturing (7-10 years)
• Extensive prior Regulatory CMC experience (7-10 years) managing complex regulatory submission strategies or equivalent combination of technical and regulatory guidance knowledge and experience.
• Demonstrated knowledge of CMC regulatory guidance.
• Demonstrated strong written spoken and presentation communication skills.
• Fluent in English with the ability to work professionally in Spanish and/or Portuguese.
• Demonstrated negotiation and influence skills.
• Demonstrated attention to detail.
• Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.

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