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’s 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’s.
• 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.
