Senior Director Regulatory Strategy

Responsibilities

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.

Assemble and present regulatory strategy to cross-functional 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.

Represent regulatory on core program teams and serve as lead regulatory affairs representative.

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.

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

Qualifications

The position is located in Boston at the 201 Brookline Ave. location.

Days and times can be flexible.

Benefits

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.

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.

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.