Regulatory Affairs Scientist
We are currently searching for a Regulatory Affairs Scientist to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Gaithersburg, MD.
Duties & Responsibilities
- Serve as a regulatory affairs management expert. Responsible for managing an Investigational New Drug (IND) application portfolio of products consisting of vaccines and monoclonal antibodies for compliance with the Food and Drug Administration (FDA) regulations for use of investigational products in humans.
- Serve as an authoritative expert on all regulatory matters concerning the development of vaccines and monoclonal antibodies. This involves strategy, implementation, review processes, submissions and compliance with the FDA, National Institutes of Health (NIH) and international regulatory authority regulations.
- Provide recommendations to the office Director on optimal strategies to advance candidate products to the clinic.
- Write and review documentation for compliance with FDA current Good Clinical Practice (cGCP), Good Laboratory Practice (GLP), and/or current Good Manufacturing Practice (cGMP). These documents include, but are not limited to, clinical study protocols, informed consent documents, case report forms (CRFs) to ensure test plans encompass all required test elements, data parameters, test objectives, chemistry manufacturing and control (CMC) documents, and nonclinical study report summaries.
- Responsible for the management and quality of the Investigational New Drug (IND) application and amendments throughout it’s lifecycle which includes writing, reviewing and/or editing the initial IND submission, IND amendments, Investigator Brochures and FDA annual reports.
- Interact with FDA project managers routinely. Responsible for pre-pre and pre-IND meetings and meeting packages, and responses to FDA queries.
- Prepare detailed reporting to the Director to ensure Sponsor responsibilities are met. This reporting includes but is not limited to the development of adequate clinical monitoring plans, adherence to the study protocol, product accountability, safety of human subjects, validity of data, and compliance with regulatory requirements.
- Develop standard operating procedures, evaluate emerging regulations and changing regulatory landscape for impacts, provide strategic advice, and communicate with stakeholders which may include recommending applicable education and training to personnel for assurance of regulatory compliance.
- Serve as liaison between the Office and other components involved in product development. Serve on product development teams as the regulatory expert.
- Master’s degree or Ph.D. in a Health Science discipline, Regulatory Affairs, or related field.
- Minimum of 3 to 5 years of experience managing INDs.
- RAC certification, beneficial.
- Skills required include both extensive theoretical and practical knowledge in the application of Title 21 Code of Federal Regulations (CFR) (GCPs, GLPs, GMPs) to ensure FDA regulatory compliance,
- Highly developed communication and negotiating skills.
- Knowledge of the scientific basis, manufacturing, preclinical studies, and clinical studies of the product.
- Knowledge of all relevant international, national and local regulations.
- Experience in eCTD submissions is highly desired.
We are a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management.
The Dovel Family of Companies offers employees an opportunity to advance beyond a specific role or contract, we offer a path to develop an enriching career. We believe in empowering a culture of innovation, customer success, and employee growth.
What you’ll get…
- Time Off! Flexible schedules and company paid holidays allow you to take the time you need.
- Investment in YOU! 401(K) company contributions are yours to keep with no waiting period.
- Choices! Unique healthcare plans to choose from with options like fertility and orthodontia benefits.
- Discovery! With our tuition assistance and training programs, we support your career advancement.
- Tax Savings! Enroll in pre-tax Health or Dependent Care Flexible Spending, HSA with company contributions, parking, and/or transit commuter benefits.
- Support! Working parents and busy professionals – we’ve got you covered with a supportive culture, confidential Employee Assistance Program and a membership to Care.com.
- Perks! Employee discounts, peer recognition programs, company-wide wellness challenges, and fun community events.
- A Voice! A unique culture where you can influence decisions and have your voice heard.
Learn more here
We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability, or veteran status.
Job posted: 2020-12-21