Regulatory Affairs Manager, CMC

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Job description

WHY CIVICA?
Because patients should have the essential medicines they need when they need them. As a rapidly growing, entrepreneurial, nonprofit generic drug company created by hospital systems and philanthropies, Civica's mission is to reduce and prevent drug shortages while assuring quality generic medicines are accessible and affordable to everyone.
Because the United States experiences chronic shortages of essential generic medicines used daily in hospitals, we are building a state-of-the-art sterile injectable manufacturing facility to combat these shortages. This new facility is part of our broad strategy to stabilize the supply of generic medicines for emergency rooms, surgeries, COVID-19 patient care, and an array of other serious conditions.

WHO CIVICA SERVES
While serving 50 health systems and 1,350 hospitals (or 30% of all licensed U.S. hospital beds), Civica also supplies the U.S. Department of Veterans Affairs, the U.S. Department of Defense, and "340B" hospitals caring for vulnerable patients in some of the country's most underserved areas. And recently, Civica contributed more than 2-million vials of essential medications to the strategic national stockpile.
With 40 sterile injectable medications under contract to supply our member hospitals, Civica is growing and on track to have 100 drugs under contract by 2023. As we continue to grow, we have many exciting opportunities for multiple types of roles and with opportunities to progress YOUR career.
To find out more about how Civica's innovative model is directly impacting patient care, click here to read a recent article from the New England Journal Of Medicine.
Commentary: The Health Care Utility Model: A Novel Approach to Doing Business

Job Description
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's 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 the 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.
• Performs final quality check of electronic regulatory submissions.
• Identifies and leads the process for obtaining feedback from key stakeholders for continuous improvement.
• Stays updated on the agency's 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.

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 ethics; 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.

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.

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%).

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.

Note: This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an "at will" relationship.
The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.

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