Vice President, Regulatory Affairs (527) - Civica Rx

About Civica:

Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. “Race to the bottom” pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.

Who suffers most? Patients.

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent 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 of essential medicines. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.”

Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.

More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.

Long- and short-acting insulins will be produced and available in both vials and pre-filled pens – at no more than $30 per vial and no more than $55 for a pack of five pens.

Learn more about Civica’s plans and progress at  www.civicarx.org

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.