Senior Director, Global Regulatory Affairs CMC - Synthetic Molecules

Company: Initial Therapeutics, Inc.
Location: Indianapolis
Posted on: April 2, 2025

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're looking for people who are determined to make life better for people around the world.Purpose:The Senior Director of Global Regulatory Affairs - CMC (GRA-CMC) leads and manages the scientific and regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and interactions with regulatory authorities for Lilly's synthetic molecule portfolio. This role ensures the integration of robust scientific principles into regulatory strategies for both development and commercial products. Additionally, the Senior Director is committed to fostering continuous improvement in regulatory practices, operational efficiency, and personnel development within the GRA-CMC organization.People Excellence - Supervision of Personnel

• Ensures that scientists in the department are highly qualified for the work assigned to them and the project responsibilities associated with their position.
• Ensures that staff understand leadership expectations for their participation on cross functional teams and regulator interactions.
• Assures recruiting of people with sound technical capabilities in Drug Substance/Drug product/Analytical related sciences.
• Assures that performance management plans and development plans are in place and maintained, performance reviews are conducted, and that staff are meeting performance expectations.
• Assures that training curricula are appropriate for department.
• Assures key talent development, reward, and recognition.
• Assures projects are resourced appropriately in the department.Technical and Regulatory Functional Excellence - Expertise
  • Recognized as a deep scientific technical expert in CMC drug development and/or pharmaceutical manufacturing technology and processes.
  • Ensures department has broad technical knowledge and expertise in global CMC regulatory requirements and guidelines for conducting clinical trials, obtaining global product registrations, and updating approved global product registrations for drug substances and drug products.
  • Utilizes specialized scientific and regulatory expertise to develop and lead implementation of new regulatory practices based on changes in the external environment.
  • Utilizes scientific and regulatory knowledge to lead preparation, review, and finalization of CMC documents for global regulatory submissions, including Clinical Trial Applications, Market Authorization Applications, post-approval supplements/ variations and responses to questions.Oversight of CMC Project Deliverables
    • Ensures appropriate definition and approves regulatory strategies for global CMC development and manufacturing changes.
    • Maintains familiarity with portfolio projects, approved products and resolves issues that occur.
    • Assures on-time delivery of regulatory plans and documents.
    • Participates in health authority interactions reviewed by FDA assessment offices and other global regulators, as needed.
    • Approves documents prior to submission to health authorities as needed.
    • Assures submissions are compliant with relevant regulations and guidance.
    • Provides regulatory sciences leadership, decision making, guidance and coaching for CMC regulatory scientists.
    • Communicates regulatory decisions and strategy to stakeholders in development, manufacturing, and quality.
    • Ensures that global CMC regulatory commitments are defined based on approved submissions for products and communicated to Manufacturing and Quality Assurance.
    • Accountable to approve use of CMC content to support submissions and share learning across regions to maximize effectiveness of global submissions.Internal and External Influence
      • Recognized as model of strong leadership behaviors and provides mentoring to GRA-CMC and other CMC related areas on technical and/or regulatory topics.
      • Defines and assures that regulatory strategies and departmental objectives are integrated with internal partners.
      • Implements strategies to influence the external environment through interaction with regulators, participation in industry technical organizations, and comment on pending draft guidance's.
      • Influences internal governance committees.Department Communications
        • Stays informed of GRA initiatives and process/policy changes impacting department & develops appropriate department goals.
        • Communicates information to scientists in the department.
        • Communicates issues and proposed solutions to Associate Vice President/Vice President and upper management as appropriate.Operational Excellence Departmental Process Management
          • Partners with other GRA-CMC Sr. Directors to ensure that internal processes are evaluated at regular intervals and that process improvement activities are conducted as appropriate.
          • Assures that the organization adheres to standards defined in the Regulatory Quality System (RQS).
          • Assures that key business practices are documented.Minimum Qualification Requirements:
            • BS, MS, or PhD in Chemistry, Biology, Engineering, or closely related science
            • 10+ years of experience in CMC development and/or technical support of commercial products and previous managerial experience.
            • 3+ years of demonstrated team leadership
            • Demonstrated scientific knowledge in drug development including API, or Drug Product or Analytical
            • Demonstrated CMC regulatory experience
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Keywords: Initial Therapeutics, Inc., Indianapolis , Senior Director, Global Regulatory Affairs CMC - Synthetic Molecules, Executive , Indianapolis, Indiana