Advisor/ Sr. Advisor - Regulatory CMC

Lilly • Indianapolis, IN

1d • $168,000 - $268,400 • Hybrid

About The Position

The purpose of the Advisor/Sr. Advisor - Global Regulatory Affairs (GRA) –CMC Platform Regulatory Scientist role is to provide strategic, tactical, and operational regulatory CMC support across therapeutic modalities and manufacturing technologies in support of clinical trials, market registrations, and post-approval activities. This role applies CMC technical knowledge and regulatory expertise to develop and execute sound global regulatory strategies, ensuring internal consistency, effective change management, and predictable regulatory outcomes. Success in this role requires building collegial and productive relationships across research, development, development, manufacturing, quality, regulatory, and partner organizations.

Requirements

• Bachelor’s degree in sciences discipline (e.g. chemistry, biology, biochemistry, pharmacy or related scientific discipline)
• Minimum of 5 years regulatory CMC experience within pharma or biotech industry

Nice To Haves

• 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.

Responsibilities

• 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.
• 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.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level