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\xe2\x80\x99s 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\xe2\x80\x99s 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\xe2\x80\x99s 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 \xe2\x80\x9cDo What Is in the Best Interest of Patients.\xe2\x80\x9d Civica\xe2\x80\x99s 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\xe2\x80\x99s innovative model is directly impacting patient care, click to read a summary from the New England Journal of Medicine. ( )

To learn more about Civica\xe2\x80\x99s plans to bring affordable insulin to Americans living with diabetes, click to read an article in BioSpace.

( )



Our Regulatory Affairs team brings essential generic quality medicines to our hospital members in the United States by providing CMC Regulatory leadership and establishing Civica\xe2\x80\x99s Regulatory Affairs systems and processes. The Manager, Regulatory Affairs CMC:

• Provides CMC regulatory leadership and support for development programs and marketed products.
• Develops product CMC regulatory strategy for essential generic medicines and obtains shortest time to approval by regulatory agencies.
• Prepares and compiles new ANDAs, Amendments, Supplements, Annual Reports, and other regulatory filings ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
• Critically reviews documentation intended for submission to the FDA for internal consistency, for consistency to relevant FDA guidelines and to promote regulatory excellence.
• Represents Civica with external organizations through direct communication with partner organizations as well as the FDA, including telephone calls and e-mail; participates in meetings between company and FDA, as assigned.
• Experience in the development or manufacture of sterile injectable pharmaceutical products and/or drug-device combination products is strongly preferred.
• Remote working opportunity is available for qualified candidates.

Responsibilities: Manager Regulatory Affairs Primary activities include, but are not limited to:

• Performs final quality check of electronic regulatory submissions.
• Identifies and leads process for obtaining feedback from key stakeholders for continuous improvement.
• Stays updated on agency\xe2\x80\x99s expectations based on guidance documents and deficiencies and applies the same logic for future submissions to avoid any similar deficiencies.
• Support change management activities.
• Assists with other Regulatory Affairs department functions as needed, including labeling/artwork management, and Office of Prescription Drug Promotion (OPDP) submissions.

What we look for:

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 for our patients.

• Support Product Development:

• Demonstrates an understanding of regulatory affairs and applies this understanding to the benefit of the company to ensure the approval and continued market supply of our products.

• Conduct all activities with an unwavering focus on compliance.

• May need to manage or mentor junior team members as well as external partners and consultants.
• Technical Skill:

• Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.

• Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strives to continuously improve and build knowledge and skills.
• Strong Listening Skills:

• Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
• Leadership Skills:

• Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders and Civica\xe2\x80\x99s partners.

• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.

• Demonstrated effective leadership, communication, interpersonal and negotiating skills. Solicits and applies customer feedback (internal and external); Improves processes, products and services.
• Teamwork:

• Balances team and individual responsibilities; Exhibits objectivity and openness to others\' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Inspires respect and trust.
• Quality Management:

• Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
• Business Acumen:

• Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals; Works within approved budget; Develops and implements cost saving measures; Contributes to profits and revenue; Conserves organizational resources.
• Diversity:

• Demonstrates knowledge of EEOC policy; Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Supports affirmative action and respects diversity; Builds a diverse workforce.
• Ethics:

• Treats people with respect; Works with integrity and ethically; Upholds organizational values.
• Strategic Thinking:

• Understands organization\'s strengths and weaknesses; Analyzes market and competition; Adapts strategy to changing conditions.
• Professionalism:

• Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments; Looks for ways to improve and promote quality; Monitors own work to ensure quality.
• Safety and Security:

• Observes safety, environmental and security procedures; Reports potentially unsafe conditions.
• Attendance/Punctuality:

• Meets timelines, manages expectations; Ensures work responsibilities are covered when absent.

Education Minimum Requirement:

B.S. in a biological or life science, engineering, or a related field (advanced degree preferred). Fields of study include Biology, Microbiology, Virology, Molecular Biology, Chemical Engineering, or Biochemistry.

Required Experience and Skills:

At least five (5) years of relevant experience, including CMC development, manufacturing, testing, or licensure of generic pharmaceutical products; or related fields. Focus in regulatory strategy and generic submissions is highly preferred. The candidate must be proficient in English; additional language skills are a plus. The candidate may be required to travel on a periodic basis (approximately 10%).

PI32112653-8722-6a6f90f3d2d8

Civica Rx