Medical Science & Computing (MSC) is an exciting growth oriented company, dedicated to providing mission critical scientific and technical services to the Federal Government. We have a distinguished history of supporting the National Institutes of Health (NIH) and other government agencies. MSC offers a dynamic and upbeat work environment, excellent benefits and career growth opportunities.
We attract the best people in the business with our competitive benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, Pre-Tax Transit Assistance and tuition reimbursement. If you enjoy being a part of a high performing, professional service and technology focused organization, please apply today!
Duties & Responsibilities
Medical Science & Computing is searching for a Director, Regulatory Science to provide support to the National Institutes of Health (NIH). This opportunity is full-time with MSC and it is on-site in Bethesda, Maryland.
- Provides leadership and guidance on regulatory matters related to the full portfolio of investigational products.
- Evaluates emerging regulations and changing regulatory landscape for impact and provides strategic advice for the branch’s portfolio.
- Provides recommendations to the Chief Medical Officer on optimal paths to advance clinical candidates based on preclinical safety data, FDA regulatory response/guidance, and experience from previous submissions.
- Oversees and provides support for all regulatory submissions. Oversees and compiles any ancillary regulatory submission components.
- Oversees and executes responses to queries and/or clarification requests (pre-IND, IND, FDA responses, and FDA meetings).
- Oversees regulatory filings by Electronic Common Technical Document (eCTD).
- Effectively manages interactions and relationships with regulatory authorities, primarily the FDA.
- Assists in the development of GLP pre-clinical/nonclinical safety testing plans, reviewing nonclinical safety data and animal toxicology studies, reviewing proposed nonclinical safety testing protocol(s) and draft reports from vendors, participating in internal and FDA meetings, performing peer reviews of nonclinical safety studies, participating in project team meetings, and visiting clinical study sites and/or testing laboratories.
- Provides strategic guidance for the life of the IND.
- Reviews and provides guidance for appropriate animal models for IND-enabling studies.
- Minimum of a Master's degree with at least 8 years of experience in regulatory affairs related to the approval of vaccines and therapeutics for human use.
- Expert knowledge of the relationship of clinical research investigators, regulatory agencies like the FDA, and others in the complex network of oversight responsibilities for the conduct of safe and effective clinical research.
- Mastery of planning, analytical, and management principles relevant to IND enabling studies and requirements for CMC activities and the clinical and pre-clinical research program.
- Ability to analyze, explain, and apply the relevant regulatory provisions in a wide variety of settings and with diverse audiences in order to advance the research program.
- High level of vision, creativity, and flexibility to advise the leadership, and others, in the development, coordination, integration, and communication of policies that affect the scientific goals and strategies of the program.
- Ability to communicate both orally and in writing sufficient to prepare and present highly complex material, often on conflicting issues, for a broad range of participants including senior level Department and agency officials, scientific community groups, and members of the public. The qualified individual must be able to make presentations to a variety of audiences and articulate the policies, initiatives and programs relevant to the activities of the program. Audiences may include individuals from a diverse cultural and/or socioeconomic background.
- The work covers a diversity of duties requiring the synthesis of knowledge, skills, and experience from different fields such as FDA regulatory management, human subjects protection requirements, strategic planning, administration, policy analysis, oral and written communication, and project management.
- Performance requires expert knowledge and ability to deal effectively and simultaneously with a large number of intricate, conceptual, scientific issues that affect resource utilization and the implementation of policies and procedures in an extremely complex and unique setting that requires adaptation of almost any standard guideline or method available.
Medical Science & Computing is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.