Vice President, Regulatory Affairs

Petersburg, VA
November 16, 2024

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Job Description

About Civica

Civica, a 501(c)(4) social welfare organization founded in 2018, aims to alleviate chronic generic drug shortages and high prices in the U.S. health system. Led by seasoned healthcare and pharmaceutical professionals, Civica has over 55 health systems as members, representing 1,500 hospitals and one-third of U.S. hospital beds. The organization supplies essential medicines to the U.S. Department of Veterans Affairs, Department of Defense, and the Strategic National Stockpile.

Recently, Civica announced CivicaScript, a unit focused on manufacturing affordable insulins for diabetes patients, set to launch in 2024. This initiative aims to provide low-cost options for those struggling with medication expenses.

Civica’s mission is to ensure accessible, affordable quality generic medications for all, guided by the principle of prioritizing patient interests. The Petersburg, Virginia manufacturing facility is under construction and will produce affordable insulin and sterile injectable medicines.

For more on Civica’s impact on patient care, read the New England Journal of Medicine summary here. To learn about Civica’s affordable insulin plans, check out the article in BioSpace here.

Job Description:

The Vice President, Regulatory Affairs will join Civica to enhance patient care by securing the supply of sterile generic injectable medications and affordable specialty medications, including insulin biosimilars.

The Vice President, Regulatory Affairs will:

  • Lead Regulatory Affairs for sterile injectable, non-sterile, and biologic/biosimilar product development and FDA approval.
  • Ensure delivery of regulatory milestones for generic and biosimilar products.
  • Provide regulatory leadership in product in-licensing, divestment, and withdrawal.
  • Oversee documentation for FDA submissions and correspondence.

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

Essential Duties and Responsibilities:

  • Lead the Regulatory CMC function and global CMC regulatory strategies.
  • Represent Civica in regulatory meetings.
  • Enhance biologic/biosimilar and sterile injectable CMC capabilities.
  • Oversee regulatory operations and ensure compliance.
  • Foster collaborative relationships and promote regulatory innovation.

Basic Qualifications and Capabilities:

We seek candidates with:

  • A scientific degree and 20+ years in global CMC regulatory affairs.
  • Leadership experience in NDA/ANDA/BLA/IND submissions.
  • Strong strategic, collaboration, and communication skills.
  • Experience in biologics/biosimilars and sterile injectables.

Physical Demands and Work Environment:

  • Ability to travel domestically and internationally, up to 20% as needed.