Eli Lilly and Company · 16 hours ago
Associate Director, Regulatory CMC
Boston, MA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$128K/yr - $213K/yr
8+ years expEli Lilly and Company is a global healthcare leader dedicated to improving lives through innovative medicines. The Associate Director, Regulatory CMC will provide strategic and operational input for regulatory activities, ensuring alignment with manufacturing and development by collaborating with cross-functional teams.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Plan, design, and implement CMC regulatory strategy including the preparation and submission of regulatory applications in a phase-appropriate manner
Manage the development of high-quality regulatory documents, including direct authoring and/or reviewing of documents such as IND/IMPD/CTA submissions, meeting requests and briefing documents, and responses to regulatory requests for information while adhering to timelines, company standards, and industry best practices
Participate in meetings with regulatory authorities; support preparatory scope of the meetings as well as manage responses to requests for information from authorities
Represent regulatory affairs on cross-functional project teams and provide guidance to and oversight of internal and external resources to ensure the company remains in compliance with applicable and phase-appropriate regulatory standards, guidelines, and best practices
Contribute to the development of risk assessment pertaining to the quality, safety, and efficacy aspects of programs and applications
Establish and maintain procedures for sourcing and document archiving to ensure efficiency and traceability of regulatory documentation
Keep up to date on changes in regulatory legislation and guidelines and research regulatory precedence from competitor products, prior approvals, and relevant external programs
Support Quality Assurance as necessary to prepare for and host inspections by regulatory authorities
Assist Regulatory leader in the development of overall CMC regulatory strategy
Qualification
Required
BS degree in a relevant scientific discipline is required
8+ years of related pharmaceutical or biopharmaceutical industry experience, with a minimum of 5 years of direct Regulatory CMC experience
Direct experience supporting interactions with global regulatory health authorities
Experience creating and submitting CTA/IND and BLA/MAA filings for complex biologics or gene therapy products
Strong knowledge of current Good Manufacturing Practices (cGMP), drug and biologics development regulations and guidelines including FDA and EMA guidelines for gene therapy and biologic products
Ability to collaborate and work in a cross-functional environment and to represent CMC regulatory on project-specific teams
CMC regulatory expertise through all stages of a product's lifecycle from early stage preclinical through marketing application
Excellent written and verbal communication skills
Demonstrated project management and organizational skills and attention to detail
Self-motivated and independent work style with the ability to initiate and follow through on assignments
Preferred
Advanced degree strongly preferred
Benefits
Company bonus
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)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
Business Standard India
2026-01-14
2026-01-14
pharmaphorum
2026-01-14
Company data provided by crunchbase