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Director, Regulatory Affairs

Philadelphia, Pennsylvania

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Req ID R-11977 Title Director, Regulatory Affairs City Philadelphia State / Province Pennsylvania Country United States Region Research

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.

Avid Radiopharmaceuticals, Inc. (Avid RP), a wholly-owned subsidiary of Eli Lilly and Company, is a molecular imaging company developing diagnostics and biomarkers that improve global health by accelerating the development of new medicines and enabling a tailored approach to healthcare. For more information, visit www.avidrp.com.

Position Overview:

Working closely with Avid and Lilly Global Regulatory Affairs (GRA) leadership, this position is responsible for developing and executing global regulatory affairs strategies, plans and programs for Avid’s radiopharmaceutical imaging and in vitro diagnostic development programs and approved products as well as supporting corporate compliance by interpreting relevant regulations.   

Responsibilities:

  • Collaborate with Lilly global regulatory colleagues, to support regulatory milestones for radiopharmaceutical and fluid diagnostic development, as well to support regulatory goals for therapeutic development, where radiopharmaceutical imaging and/or other diagnostics are included in the trial design

  • Establish and implement, in collaboration with leadership, global strategic regulatory goals for Avid’s development programs and approved products, globally in collaboration with leadership

  • Prepare and file INDs, IND amendments, CTAs, marketing applications, and other regulatory submissions, and work closely with functional leaders of the company to produce high quality submissions
  • Serve as primary contact for Regulatory Agency interactions for Avid products
  • Anticipate and identify regulatory risks and make recommendations to senior management regarding risk mitigation
  • Lead and manage the authoring and coordination of periodic regulatory and/or safety reports for investigational and approved Avid products
  • Lead and manage the authoring and coordination of approved product Annual Reports to regulatory agencies
  • Manage the electronic archive and catalog all submissions to and communications with regulatory agencies
  • Liaise with external vendors and Lilly support departments to maintain productive relationships, supporting efficient regulatory document preparation and submission activities
  • Maintain Avid entries in clinical trial registries including clinicaltrials.gov
  • Maintain departmental procedures, identify opportunities for process improvement, and propose implementation plans
  • Support pharmacovigilance and risk management activities for development products
  • Lead the post-marketing regulatory activities for Avid, such as: planning and managing post-approval regulatory submissions, advising marketing and sales management regarding regulatory aspects of product education and promotion activities
  • Manage the regulatory department; responsible for coaching, developing and mentoring staff
  • Other duties as assigned

Basic Qualifications:

  • Bachelor’s degree
  • Minimum of 5 years of regulatory affairs experience

Additional Skills/Preferences:

  • An advanced degree in a scientific discipline relevant to drug discovery and development preferred
  • A minimum of 10 years of regulatory affairs experience in a corporate drug development organization preferred
  • A high level of familiarity and understanding of FDA and ICH regulations and guidelines, both broadly across drug development, but also specifically those that apply to radiopharmaceuticals and fluid diagnostics.
  • Several years of experience in medical imaging drug development and direct experience working with medical imaging division of FDA is preferred
  • Fluid diagnostic regulatory experience preferred
  • Good working knowledge of applicable regulations, such as GLP, GMP, GCP and OPDP regulations

Additional Information:

  • Lilly currently anticipates that the base salary for this position could range from between $133,000 to $194,500 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. 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).Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, 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.
  • As a condition of employment with Eli Lilly and Company in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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 in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.
 

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-11977.

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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