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Organizational Overview:
Verve Therapeutics, a wholly owned subsidiary of Eli Lilly & Company, is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, Verve is pioneering a new approach to the care of cardiovascular disease, potentially transforming treatment from chronic management to single-course gene editing medicines.
Position Summary:
The Associate Director, Regulatory CMC will work closely with cross-functional subject matter experts to provide strategic and operational input for CMC regulatory activities including submissions, reviews, and health authority interactions. You will be responsible for ensuring alignment of regulatory strategies with manufacturing and development activities by partnering with Technical Operations, Process Development, Analytical Development, Quality, and other cross-functional stakeholders.
Understanding program timelines and deliverables, you will develop regulatory strategies integrated with cross-functional project teams and external vendors to coordinate and implement submission strategy and content. You will develop and maintain relationships with health authorities as required and help to support the preparation of health authority interactions with respect to CMC issues. Develop/assess project plans and timelines effectively to ensure projects are appropriately prioritized and goals are met.
Support development of manufacturing and control strategies, including assessing proposed manufacturing process and analytical method changes and provide strategic regulatory guidance on phase appropriate considerations and comparability needs. Stay abreast of regulatory guidelines and trends related to CMC; interpret regulations and guidance to provide advice.
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.
Basic Requirements:
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.
Additional Preferences:
Advanced degree strongly preferred
Other Information:
This role will be based in Boston, MA
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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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.
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Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$127,500 - $213,400Full-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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