Hiring company: Lilly
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 35,000 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.
About Prevail Therapeutics
Prevail Therapeutics, a wholly owned subsidiary of Eli Lilly and Company, is focused on developing novel gene therapies for Parkinson’s disease and other genetically defined neurodegenerative diseases. Prevail is based in New York city at the Alexandria Center for Life Sciences.
Position Summary
The Manager/Sr. Manager of Global Regulatory Affairs will assist in the development and coordination of global regulatory strategy and deliverables for multiple programs in several countries. Working in collaboration with Nonclinical, Clinical, CMC, Program Management, and Executive Leadership teams, this position will coordinate and prepare for interactions with health authorities, support premarket regulatory submissions, and direct the completion of regulatory dossiers. We are looking for an enthusiastic, self-motivated, and collaborative person with excellent interpersonal skills.
Key Responsibilities
- Participate in cross-functional program/study team activities to support clinical trial applications and provide regulatory guidance as needed.
- Assist with development and submission of high-quality regulatory documents (e.g. INDs, CTAs, Amendments, Orphan Drug Applications, Pediatric Study Plans, Regulatory Designation Requests, Special Protocol Assessment requests, Marketing Applications, Annual Reports, and Responses to Health Authority questions).
- Routinely track and communicate implications of changing global regulatory requirements (e.g. health authority guidance/guidelines, regulatory policies, overall environment relevant to gene therapy).
- Support the planning and execution of global health authority interactions including generation and submission of briefing books, follow-up responses, and other communications.
- Contribute to identification of potential issues/gaps and propose creative risk mitigation strategies to address gaps affecting optimal and timely submission and approval.
- Develop and submit annual reports and other health authority commitments.
- Assess and communicate regulatory requirements to ensure development activities are in compliance with applicable regulations and guidelines.
Minimum Requirements
- Bachelor’s degree in life sciences or related field.
- At least 3 years direct regulatory affairs experience.
- Knowledge and experience in the preparation of global regulatory submissions including maintenance activities.
Additional Skills and Preferences
- Advanced degree preferred (PharmD, PhD).
- Strong knowledge of GXPs and ICH guidelines in clinical trials.
- Ability to lead and influence project teams, committees, etc. to attain group goals.
- Excellent oral and written communication skills.
- Strong interpersonal and leadership skills.
- Demonstrated ability to analyze and resolve problems.
- Demonstrated ability to lead programs / projects. Ability to document, plan, market, and execute programs.
- Established project management skills.
- Experience in gene therapy, siRNA, neurodegeneration and/or rare disease is preferred, but not required.
Additional Information
- Primary Location-New York with the possibility to work remotely as a secondary option.
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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an accommodation for medical or religious reasons, you may do so at workplace_adjustment@lilly.com.