Senior Director Regulatory Strategy

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Organization Overview: 

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.

Responsibilities:

The Senior Director, Regulatory Affairs is responsible for planning, developing, and implementing regulatory strategy, submissions, and compliance activities for gene-editing programs in early development to support regulatory approvals. The Senior Director, Regulatory Affairs serves as the main regulatory lead for assigned development programs and represents regulatory on core program teams. This position will report to the Executive Director, Regulatory Affairs.

• Lead 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 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 guidelines.
• Act 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.
• Serve as lead regulatory affairs representative 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 protocols.
• Provide regulatory input for risk assessments pertaining to the quality, safety, and efficacy aspects of programs and applications.
• Keep up to date on changes in regulatory legislation and guidelines and research regulatory precedence from competitor products, prior approvals, and relevant external programs.

Basic Requirements: 

Bachelors degree with 10+ years demonstrated experience in pharmaceutical/ biotechnology environment, with 5+ years in Regulatory

Additional Skills/Preferences:

Direct experience with the following is preferred but not required:

• 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
• 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
• Cardiovascular disease
• Gene therapy, especially gene editing mechanism
• Nonclinical development
• Experience working in highly matrixed team
• Veeva Vault
• Organizational integration

Additional Information:

• The position is located in Boston at the 201 Brookline Ave. location.
• There is an expectation that applicants will be in the office three days per week. Days and times can be flexible.

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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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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