Senior Regulatory Affairs Scientist
About this role
Description
Senior Regulatory Affairs Scientist
Venesco LLC is seeking a Senior Regulatory Affairs Scientist to serve as a senior regulatory subject matter expert responsible for developing regulatory strategies, leading FDA interactions, managing submissions, and ensuring compliance throughout the medical product lifecycle.
Requirements
Duties and Responsibilities
- Develop regulatory pathways and approval strategies.
- Lead preparation and review of FDA submissions.
- Serve as regulatory lead for assigned programs.
- Provide regulatory risk assessments and mitigation strategies.
- Support FDA meetings and agency interactions.
- Create and maintain Target Product Profiles.
- Monitor regulatory intelligence and emerging requirements.
- Review product development documentation.
- Mentor junior regulatory personnel.
- Lead SOP and process improvement initiatives.
Minimum Qualifications
- Master's degree or higher in Life Sciences, Pharmacy, Regulatory Affairs, or related field.
- Regulatory Affairs Certification (RAC) required.
- Minimum 12 years of FDA regulatory affairs experience.
- Extensive experience preparing INDs, NDAs, BLAs, IDEs, and 510(k) submissions.
- Experience interacting directly with FDA review divisions.
- Strong leadership and mentoring experience.
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, ethnicity, religious affiliation, gender, gender identity or expression, sexual orientation, 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.
For more information on Venesco, LLC., visit https://venesco.com.
Company at a glance
Venesco, LLC is a premier government contractor delivering Healthcare, IT, Research & Development, and a range of mission‑critical services to federal agencies. For more than 18 years, we’ve evolved from a small consulting firm into a respected leader in biomedical R&D and IT support, backed by strong financials, mature processes, and a commitment to employee connectedness and work–life balance.
Our success is driven by our skilled professionals, agile management practices, and high‑quality standards. Venesco holds a Top‑Secret Facility Clearance and maintains CMMI® Maturity Level 3 (Services) and ISO 9001:2015 and 14001:2015 certifications. We’ve been recognized on the Inc. 5000 and Washington Technology’s Fast 50 lists for five consecutive years.
With more than 350 credentialed employees and 65+ prime contracts — ranging from small teams to programs with 150+ personnel — we deliver the impact of a large enterprise while maintaining the agility of a small business. Venesco continues to recruit motivated, talented individuals who want to contribute to meaningful federal initiatives and join a collaborative, high‑performing team.
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