Vice President, Regulatory Affairs

Company: Civica Rx
Location: Petersburg
Posted on: November 11, 2024

Job Description:

About Civica Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders. Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran's Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile of essential medicines. Civica recently announced plans to expand its mission, via a unit called CivicaScript, to into the outpatient pharmacy space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. The availability of Civica's affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications. Civica's mission is to ensure that quality generic medications are accessible and affordable to everyone. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients." Civica's manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway. To find out more about how Civica's innovative model is directly impacting patient care, click here to read a summary from the New England Journal of Medicine. (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189) To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace. (https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/) Job Description: The Vice President, Regulatory Affairs will join the Civica, Inc. ("Civica") organization and its team by bringing 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 and insulin biosimilar analogs to patients within the United States. The Vice President, Regulatory Affairs:

• Leads Regulatory Affairs for sterile injectable, non-sterile, and biologic/biosimilar product development (including biologic/device combination products), review, submission, and FDA approval of Civica's medication portfolio.
• Is accountable for the delivery of all regulatory milestones for generic and biosimilar products including assessment of the probability of regulatory success together with risk mitigation measures.
• Provides regulatory leadership as needed in product in-license / due diligence review, product divestment and product withdrawal.
• Leads the regulatory team in the development and compilation/publishing of documentation for U.S. FDA investigational new drug (IND), European Medicines Agency clinical trial application (CTA)/investigational medicinal product dossier (IMPD), Abbreviated/New Drug Applications (A/NDA), and biologics license application (BLA) submissions, FDA meeting requests, and correspondence and responses to questions from regulatory authorities, including FDA. 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 the Regulatory CMC function to support the CMC portfolio goals with proven track record of successfully building and leading teams.
  • Lead global CMC regulatory strategies for projects in development and marketed products, including risk mitigation strategies to ensure approvals and maintenance of product licenses.
  • Leads and represents Civica in regulatory meetings.
  • Strengthen biologic/biosimilar and sterile injectable CMC capability by working with internal stakeholders and external partners to evaluate and enable biosimilar approvals.
  • Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in Research and Development, Regulatory Affairs, and Clinical Development.
  • Exercise expertise in the interpretation and implementation of FDA guidelines with a goal of an approved/ harmonized regulatory control strategy.
  • Ensure regulatory conformance & consistency for assigned products in compliance with regulatory requirements and internal procedures.
  • Oversee regulatory affairs operations including the VEEVA regulatory information management (RIM) platform, and the artwork management system for both Civica owned and private label distribution products.
  • Partner across the CMC functions in the company, and other functional groups at Civica to support opportunities for regulatory innovation / promote the use of novel approaches within project teams to resolve issues and problems.
  • 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 CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD.
    • Demonstrated organizational leadership skills at both functional and enterprise levels.
    • Experience with leading NDA/ANDA/BLA/IND/IMPD/CTA submission and approvals including Health Authority interactions.
    • Application of sound and accurate judgment to make timely decisions.
    • Biologics/biosimilar and sterile injectable experience is preferable.
    • Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.).
    • Demonstrated success in leading complex groups to support operational goals and contribute to the development of global regulatory initiatives.
    • Excellent strategic acumen, collaboration, and communication skills are required.
    • Excellent interpersonal, verbal, and written communication skills.
    • Proven success in:
      • Strategic thinking capability with business acumen to allow an understanding of how the parts impact the enterprise
      • Direct support of the submission and approval of regulatory applications, amendments and changes including resolution of information requests
      • Large scale quality management experience including the design and implementation of effective and compliant quality processes, procedures and tools
      • Exceptional problem-solving skills to foster the development and implementation of risk-based compliant solutions to business and regulatory challenges
      • Providing quality and regulatory input across the development and product lifecycle
      • Process and analytical development and commercial knowledge to facilitate root cause analysis and effective solutions and corrective measures
      • Building and maintaining complex collaborative relationships capable of influencing the delivery of aligned compliant solutions and decisions
      • Creating a future vision and gaining support and alignment to that vision
      • Building consensus and impact outcome without always having line authority
      • Negotiating trade off decisions across the organization Physical Demands and Work Environment:
        • Ability to travel in the U.S. and internationally, as needed, for contract manufacturing oversight and Civica manufacturing site. Travel of up to 20% may be required. PandoLogic. Keywords: VP Compliance, Location: Petersburg, VA - 23803 , PL: 594965142

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