Director, Biologics Regulatory Affairs

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 Director, Biologics Regulatory Affairs will join the Civica, Inc. (“Civica”) organization and its team in support of the Civica Foundation by bringing their knowledge and experience in service to patients and pursuit of excellence in quality to supply affordable insulin biosimilar products. The Director, Biologics Regulatory Affairs:

• Leads CMC Regulatory for biosimilar product development (including biologic/device combination products), review, submission, and FDA approval of the Civica Foundation biosimilar insulin portfolio.
• Is accountable for the delivery of all regulatory milestones for 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.
• Manages 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) and Biologics License Application (BLA) submissions, FDA meeting requests, and correspondence and responses to questions from regulatory authorities, including FDA.

Essential Duties and Responsibilities:

Director, Biologics Regulatory Affairs primary activities include, but are not limited to:

• Develops product regulatory strategy for the biosimilar portfolio (including biologic/device combination products) to achieve shortest time to approval by regulatory agencies.
• Directs the development and submission of investigational new drug (IND) applications and marketing applications (e.g., BLA and abbreviated new drug applications (ANDA)), and any required amendments, supplements, and periodic reports.
• Provides expert advice to Product Development Teams and Civica management on regulatory strategy and issues as they arise with the developmental biosimilars or marketed products throughout the entire life cycle of the drug.
• Provides leadership to the staff by leading a team of both internal and external individuals. Coordinate cross-functional regulatory support for development programs and marketed products.
• Represents Civica with external organizations through direct communication with the FDA and other regulatory agencies as applicable, including telephone calls and e-mail; chairs meetings between company and FDA; prepares Civica teams for meetings with FDA at any phase of drug development.
• Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registrations and coordinates and answers any questions.
• Provides advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
• Conducts initial IND and BLA content review.
• Leverages technology in the preparation of regulatory documents and submissions.
• Participates in regulatory due diligence activities for licensing candidate reviews.
• Contributes to the development and optimization of systems and procedures for managing all aspects of the regulatory process.

Basic Qualifications and Capabilities:

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 of 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.
• Conducts all activities with an unwavering focus on compliance.
• Manages or mentors team members as well as external partners and consultants.

Technical Skills:

• 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’s 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.; Continually works to improve supervisory skills.

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; 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; 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 fifteen (15) years of experience (10 years with an advanced degree) in U.S. Regulatory Affairs, supporting both investigational (IND) and marketing applications (BLA, NDA or ANDA) for sterile injectable and/or biologic drug products. Preferred qualifications include experience with biological manufacturing or testing and knowledge of regulatory requirements related to the development and licensure of biosimilar and combination products. The candidate must be proficient in English. The candidate may be required to travel on a periodic basis (5-20%).