Venesco LLC is looking for a Level V Regulatory Affairs Manager. This is a remote-working opportunity for a regulatory affairs / quality assurance scientist who fully understands FDA requirements and has experience with Good Clinical Practice (GCP) of clinical trials of drugs, biologics, and/or devices. This position supports our government client, One Network of Excellence for Regulatory Affairs and Quality Assurance (ONE-RAQA) at Fort Detrick, MD.
This position requires a SECRET clearance.
- The contractor shall provide expert analysis and regulatory advice, management and oversight across the total lifecycle management of medical products from early product development through interim fielding (emergency use regulatory mechanisms) to approval, clearance or licensure and throughout post marketing as appropriate.
- The contractor shall support and or execute regulatory portfolio management, developing and reviewing regulatory documents (Target Product Profile, Regulatory Strategies, Regulatory White Papers, regulatory briefings, etc.) including executing and overseeing development of documents for other internal and external regulatory agencies as needed.
- The contractor shall lead or assist the development and review of regulatory documents for submission to the FDA or other National Regulatory Authorities (NRAs).
- The contractor shall create and/or review acquisition and contract documents to ensure regulatory and quality requirements are appropriate and consistent with FDA regulations and assess the impact of these requirements to the product development timeline.
- The contractor shall read, review and provide comments in the evaluation of non-clinical, clinical, and manufacturing documentation to ensure appropriateness, accuracy, and applicability to appropriate regulatory guidance.
- The contractor shall be a regulatory team member on interdisciplinary teams and provide regulatory guidance and oversight on regulatory and quality matters during the medical product development process.
- The contractor shall provide regulatory and/or quality advice and oversight to ensure all product development efforts are compliant with good laboratory, pharmaceutical development, manufacturing practices and clinical practices (cGxPs).
- The contractor shall ensure that all regulatory and quality processes are effectively implemented and that all regulatory and quality documentation is controlled, maintained, stored, archived, protected and retrievable per applicable policies and procedures.
- The contractor shall assist relevant stakeholders in their understanding of the scientific complexity of the research and development efforts and compliance with regulatory and quality regulations surrounding those efforts.
- The contractor shall provide regulatory expertise in other areas affecting the development process (e.g., Requests for Proposals (RFPs), Source Selection Evaluation Boards (SSEBs), etc.).
- The contractor shall provide regulatory input into the evaluation of candidate technologies throughout the product development lifecycle to determine the appropriate technology/manufacturing readiness level, foster timely pharmaceutical based decision making and ensure efficient and appropriate transitions through the regulatory and advanced development stages.
- The contractor shall collaborate and network with internal/external regulatory professionals and clinicians, as well as investigators and researchers, and other scientific and technical disciplines to maintain current knowledge in the Chemical, Biological, Radiological, and Nuclear (CBRN), Emerging Infectious Disease (EID), and other relevant emerging and re-emerging threat spaces.
Education, Experience and/or Certifications Required:
- Standard Requirement: The contractor shall possess an advanced degree in Life Sciences, Public Health, Medical, Nursing, Pharmacy, Veterinary, Business, Technical or Medical Writing, or a related discipline, as well as fifteen (15) years of general experience and ten (10) years of relevant experience.
- Tradeoff Requirement: The contractor shall possess a Bachelor’s or Master’s degree in Life Sciences, Public Health, Science, Medical, Nursing, Pharmacy, Veterinary, Business, Technical or Medical Writing, or a related discipline, as well as twenty (20) years of general experience and fifteen (15) years of relevant experience.
- The contractor shall be capable of maintaining interpersonal contacts to increase effective team dynamics; effectively communicating ideas, requirements, and scientific knowledge; and self-starting.
- Preferred: Certification in Regulatory Affairs or other certification relevant to medical product development and/or audit, is desired and will be at no cost to the Government.
- The contractor shall possess and maintain a mastery of FDA regulations, inferences, and regulatory requirements, and have the capability to interpret and apply them to COVID-19 Product Development and Fielding efforts.
- The contractor shall possess expert knowledge in regulatory affairs and quality assurance as it relates to pharmaceutical development, as well as previous experience applying this knowledge in a regulatory/quality organization providing support throughout the product development lifecycle including pre-clinical, non-clinical and clinical study development and implementation, and medical product manufacturing development efforts. In addition, the contractor shall be capable of applying this expert knowledge to complex technical problems with minimal supervision.
Venesco LLC, is an equal opportunity and affirmative action employer. Venesco is committed to administering all employment and personnel actions on the basis of merit and free of discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or status as an individual with a disability. Consistent with this commitment, we are dedicated to the employment and advancement of qualified minorities, women, individuals with disabilities, protected veterans, persons of all ethnic backgrounds and religions according to their abilities.
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