About Civica:

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.

Shortages put patients at risk and waste hospital resources.

Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile with essential medicines. Civica currently supplies medicines to health system members in 49 states.

Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.

Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.

The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative. 

Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.

Join us. Learn more at  www.civicarx.org

Job Description:

The Manager, Regulatory Affairs, PLD will bring their knowledge and experience in service to patients and pursuit of excellence to secure and stabilize the supply of sterile generic injectable medications and provide affordable specialty medications to patients within the United States.  

The Manager, Regulatory Affairs PLD leads all processes in regulatory affairs related to working with and maintaining our PLD partners, including developing flexible processes to meet the needs of Civica and our partners with respect to Labeling, Artwork, and Promotion review

This role offers a flexible remote work style with travel to Civica’s Petersburg, Virginia manufacturing facility and Lehi, Utah office as needed.

Essential Duties and Responsibilities:

• Lead Labeling and Artwork activities with various partners to support all PLD programs.
• Update and maintain labeling in compliance with regulatory standards and in support of PLD programs.
• Review and approve artwork files.
• Build processes for labeling and artwork and standardized ways of working.
• Review promotional pieces for PLD partnerships.
• Lead administrative label process in Veeva.
• Lead administrative and submission processes in Veeva.
• Provide input to Quality team for labeling SOP
• Develop meaningful and collaborative relationships with internal/ external partners.
• Demonstrate success in influencing without positional authority within a highly matrixed organization.

Basic Qualifications and Capabilities:

We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue doing what is in the best interest of our patients.

What we look for:

• A scientific degree with directly relevant professional experience in global regulatory affairs and regulatory operations of at least 8 years.
• Demonstrated organizational leadership skills
• Application of sound and accurate judgment to make timely decisions.
• Excellent strategic acumen, collaboration, and communication skills are required.
• Excellent interpersonal, verbal, and written communication skills.
• Proven success in:
  • FDA label negotiations
  • Lead internal label development in a matrixed environment
  • Interpreting regulations on labeling and presenting cohesive annotated labels to clients

Physical Demands and Work Environment:

• Ability to travel in the U.S. and internationally, as needed, up to 20% may be required.
• Flexible availability to engage in partnership conversations on the East and West coasts in the USA.