Job Description

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\xe2\x80\x99re 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 GRA-CMC-AP role is to provide strategic, tactical, and operational direction to expedite CMC development of Lilly\xe2\x80\x99s portfolio and to develop successful regulatory strategies to support market registrations and product life-cycle maintenance in Asia Pacific (AP) including Japan, China, Australia, New Zealand, Korea, Taiwan, Singapore, ASEAN Alliance and India. This is accomplished with a strong working knowledge of global and AP-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, coordinate with Japan and China regulatory colleagues, partner with company representative, and AP-regional regulatory agency personnel. This role is further accomplished by a demonstrated ability to establish and/or to promote / refine key regulatory CMC positions and to effectively influence Business Units, M&Q and GRA leadership on these positions.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 AP 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 AP-region submission timing.
• Reviews and approves CMC documents for product registrations in AP Region, and networks with GRA-CMC and manufacturing site regulatory scientists 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-CMC-AP objectives and partner requirements.

Influence

• Networks independently with upper management GRA, M&Q, and BU leadership, as appropriate, 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 AP region.
• Recognized as model of strong leadership behaviors and provides mentoring to affiliates, GRA CMC, M&Q and RDE/LCCI 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 efficiencies.
• Influences policy and emerging regulations in AP region for CMC issues (internally and externally).
• Leads initiatives within industry organization(s), effectively increasing Lilly\xe2\x80\x99s visibility and influence of evolving regulatory positions.

Leadership, Collaboration and Partnering

• Independently develops complex AP-regional CMC regulatory strategies and networks for alignment across BU, MIH, TS/MS, Quality, GRA, and affiliates/Geos, as required, to enable timely completion of AP-regional submission milestones.
• Partner with GRA, Geos, affiliates to pursue fast as possible regulatory pathways.
• Takes a proactive leadership role and coordinates with Japan, China, and AP-regional colleagues in the critical review of CMC development strategies and submission content for global and AP-regional registrations and response to question submissions.
• Proactively identifies and resolves AP-regional CMC regulatory issues, leveraging internal experts to develop complex regulatory strategies.
• Communicates effectively verbally and in writing to lead and influence across GRA, affiliates, GRA CMC, TS/MS, quality, RDE/LCCI at the junior, peer and management levels. Within work group/function and with project team.
• Participates and leads forums that share AP-regional regulatory information across Lilly.
• Leads efforts for the development of corporate positions on, and responses to proposed agency regulations and guidelines in the AP 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) handling complex regulatory submission strategies or equivalent combination of technical and regulatory guidance knowledge and experience.
• Demonstrated knowledge of CMC regulatory guidance\xe2\x80\x99s.
• Demonstrated strong written, spoken and presentation communication skills.
• Fluency in English and AP-regional language(s).
• Demonstrated negotiation and influence skills.
• Demonstrated attention to detail.
• Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.#WeAreLilly

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