ClinicalRM is seeking an FDA Regulatory Expert for the 59th Medical Wing at Lackland Air Force Base in San Antonio, TX .
Assists in the day to day management of all types of FDA scientific regulatory reviews to ensure the safety and efficacy of human drugs, foods, animal drugs, medical devices and biologicals.
Prepare regulatory filings and handle subsequent interactions related to annual requirements for establishment of registrations and device listings and any additional compliance reporting for FDA.
Serves as an FDA regulatory expert, and is responsible for assuring timely resolution of scientific regulatory conflicts or problems to avoid delays in achieving goals.
Provides support to research teams by providing guidance on the scientific regulatory process in order to determine how much progress is being made and if any problems are surfacing.
Provides advice and counsel to all parties engaged or interested in the FDA scientific regulatory process concerning the assigned area of study.
Assists in communicating directly with regulated industry counterparts to resolve issues, and facilitate technical information gathering for reviewers and regulators.
Provides assistance for regulating all necessary processes and guidelines being managed.
Will serve as an appointed non ‐ voting member of the Institutional Review Board, observing and providing FDA guidance.
Provide all job-related progress reports/technical reports as requested.
Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations.
Performs light duties and other related duties as required and assigned.
Ph.D or Masters Graduate Degree in scientific discipline, with a minimum of three years experience working all types of FDA scientific regulatory reviews.
Possess a thorough knowledge of recent developments in the scientific discipline and associated scientific disciplines; applicable FDA laws, regulations, policies, procedures, scientific guidelines, scientific information on unexpected side effects, injury, toxicity or scientific reactions associated with the regulated products and related products.
Possess current certification in Basic Life Support (BLS). The contractor is responsible for maintaining the certification in a current status throughout the life of this contract.
Must be able to work independently following a brief period of specific technical training.
Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, or national origin.
ClinicalRM is an Affirmative Action-Equal Opportunity Employer
Clinical Research Management - 18 months ago