Senior Director Regulatory Strategy

Eli Lilly and Company • Boston, MA

6d • Hybrid

About The Position

Verve Therapeutics Inc., a Wholly Owned Subsidiary of Eli Lilly and Company, is developing gene editing medicines for serious diseases. Regulatory affairs collaborates cross functionally within Verve and Lilly to build fit-for-purpose development plans and engage global health authorities. Regulatory affairs is seeking a dynamic leader with a growth mindset interested in building successful regulatory strategies. Verve is located in Boston, just down the road from Fenway Park.

Requirements

• Bachelors degree with 10+ years demonstrated experience in pharmaceutical/ biotechnology environment, with 5+ years in Regulatory
• Excellent written and verbal communication skills
• Demonstrated project management and organizational skills
• Self-motivated and independent work style with the ability to initiate and follow through on assignments

Nice To Haves

• Direct experience with complex biologics preferred
• Advanced degree preferred
• Working knowledge of domestic and international regulations and guidelines regarding phase-appropriate drug development, along with the application of principles, theories, and practices
• Direct experience interacting with relevant regulatory authorities
• Cardiovascular disease
• Gene therapy, especially gene editing mechanism
• Nonclinical development
• Experience working in highly matrixed team
• Veeva Vault
• Organizational integration

Responsibilities

• Planning, developing, and implementing regulatory strategy, submissions, and compliance activities for gene-editing programs in early development to support regulatory approvals.
• Serving as the main regulatory lead for assigned development programs and representing regulatory on core program teams.
• Leading the planning, design, and implementation of clinical, nonclinical, and CMC regulatory strategy including the preparation, submission, and maintenance of regulatory applications in a phase-appropriate manner.
• Independently managing 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 guidelines.
• Acting as regulatory contact with regulatory authorities, including engaging in meetings with regulatory authorities and managing meeting requests and responses to requests for information from authorities.
• Serving as lead regulatory affairs representative on cross-functional project teams and providing 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 protocols.
• Providing regulatory input for risk assessments pertaining to the quality, safety, and efficacy aspects of programs and applications.
• Keeping up to date on changes in regulatory legislation and guidelines and researching regulatory precedence from competitor products, prior approvals, and relevant external programs.

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: Senior