Manager, Regulatory Affairs

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 Veterans 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.

Civicas 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.

Civicas 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 Civicas work to manufacture and distribute affordable medications. The Foundations first commitment is to support Civicas 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 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

• Lead ANDA and BLA writing and review.
• Assist in developing and maintaining working templates for ANDA and BLA, including Mod 3-5.
• Assist in developing and maintaining standardized ANDA and BLA submission processes.
• Author specialized, preformatted, facility sections to create a facility core dossier (DMF)
• Support Labeling operations across Civica, including CivicaRX and CivicaScript.
• Review Petersburg Facility projects/changes for product impacts and coordinate with RA team

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

Essential Duties and Responsibilities:

• Lead core dossier development and implementation
• Support the Regulatory BLA and ANDA team to create high quality submissions.
• Leads and represents Civica in regulatory meetings.
• Lead and administrate VEEVA regulatory information management (RIM) platform which uses end to end publishing
• 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 5 years with a BA/BS
• 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:
  • Direct support of the submission and approval of regulatory applications, amendments and changes including resolution of information requests
  • Creating and implementing core systems and dossiers to assure efficiency in regulatory business operations
  • Strategic thinking capability with business acumen to allow an understanding of how the parts impact the enterprise
  • Building and maintaining complex collaborative relationships capable of influencing the delivery of aligned compliant solutions and decision

Physical Demands and Work Environment:

• Ability to travel in the U.S. and internationally, as needed, for contract manufacturing oversight and Civica manufacturing site located in Petersburg, VA. Travel of up to 20% may be required.