Advisor/ Sr. Advisor - Regulatory CMC

• Apply strong technical knowledge of CMC drug development and pharmaceutical manufacturing sciences across drug substance, drug product, and analytical areas.

• Demonstrates broad knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials, obtaining global product registrations, and maintaining approved registrations.

• Develops, implements, and maintains global CMC regulatory strategies in response to evolving regulatory expectations and program needs.

• Provides high-quality, timely regulatory advice to enable informed development, manufacturing, and lifecycle planning decisions.

• Evaluates the regulatory impact of proposed CMC development, manufacturing, or change strategies and identifies risks and mitigation options.

• Leads preparation, review, and finalization of CMC documents for global regulatory submissions, including clinical trial applications, marketing applications, variations/supplements, and responses to health authority questions.

• Anticipates and resolves technical or operational issues that could impact submission timing, regulatory compliance, or product supply.

• Independently manages technically challenging or complex issues and proposes practical, risk-based regulatory solutions.

Influence

• Build strong working relationships across Global Regulatory Affairs, research and development, manufacturing, quality, and regional/affiliate regulatory teams to drive alignment on CMC regulatory strategies.

• Provides regulatory guidance and subject matter expertise to CMC teams and stakeholders to support successful submissions and approvals.

• Exhibits strong leadership behaviors and is recognized as a trusted mentor and resource within the regulatory CMC community.

• Incorporates new regulations, guidance, and company positions into processes, tools, templates, and training materials to support consistent execution.

• Provides input into internal policy development and contributes to internal discussions on emerging global CMC regulatory trends.

• Participates in industry forums or working groups, as appropriate, to maintain awareness of evolving regulatory expectations.

• Leads or supports cross-functional teams in the development and execution of global CMC regulatory strategies.

• Takes an active role in the critical review of CMC development strategies, control strategies, and submission content to ensure regulatory robustness.

• Collaborate effectively with manufacturing sites, technical experts, and quality organizations to resolve regulatory issues and support timely delivery of commitments.

• Supports health authority interactions for CMC topics, including preparation of briefing materials and responses to questions, as appropriate.

• Communicate regulatory strategies, risks, and recommendations clearly and effectively to team members and stakeholders.

• Participates in forums that share regulatory knowledge, lessons learned, and best practices across the organization.

• Contributes to the development of corporate positions and responses to proposed agency regulations and guidelines relevant to CMC.

7 + years pharmaceutical industry experience in CMC technical drug development

Prior experience authoring CMC submission content

Demonstrated strong written, spoken and presentation communication skills.

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 ( https://careers.lilly.com/us/en/workplace-accommodation ) 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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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