Regulatory Affairs LeadVirtualVocations • Rockville, Maryland, United States
Regulatory Affairs Lead
VirtualVocations • Rockville, Maryland, United States
job_description.job_card.1_day_ago
serp_jobs.job_preview.job_type
- serp_jobs.job_card.full_time
job_description.job_card.job_description
A company is looking for a Regulatory Affairs Lead, IND / IDE.
Key Responsibilities
Advise on regulatory pathways, product classification, and study design considerations
Lead FDA engagement and manage original and maintenance submissions under 21 CFR 312 / 812
Establish and maintain SOPs, mentor regulatory staff, and ensure audit / inspection readiness
Required Qualifications
Advanced degree in a relevant field or equivalent experience
Minimum eight years of progressive regulatory affairs experience with a focus on IND / IDE submissions
Deep knowledge of 21 CFR 312 / 812, ICH-GCP, and familiarity with device quality systems
Experience within an academic medical center or complex research environment
Exceptional technical writing and project management skills
serp_jobs.job_alerts.create_a_job
Regulatory Lead • Rockville, Maryland, United States
Job_description.internal_linking.related_jobs A company is looking for a Regulatory Affairs Lead, IND / IDE.Key Responsibilities Advise on regulatory pathways, product classification, and study design considerations Lead FDA engagement and ma...serp_jobs.internal_linking.show_more A company is looking for a Product Development & Regulatory Specialist who is passionate about clean, compliant, and innovative beauty.
Key Responsibilities Manage and maintain Product Informa...serp_jobs.internal_linking.show_more A company is looking for a Sr Manager Regulatory Affairs - Labeling, Advertising and Promotions (Remote).Key Responsibilities : Guide and coordinate regulatory strategy for labeling, advertising, ...serp_jobs.internal_linking.show_more 
Monday through Friday, 8 : 00 AM - 5 : 00 PM (with some flexibility).Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate ...serp_jobs.internal_linking.show_more)
JSI invites you to join our team as a.Consultant, Regulatory Affairs.Regulatory Services team in Orlando, FL, Greenbelt, MD, Charlotte, NC, or Austin, TX, where you'll play a critical role in advan...serp_jobs.internal_linking.show_more A company is looking for a Director, US Regulatory Intelligence & Policy Lead.Key Responsibilities Lead the acquisition, analysis, communication, and management of US regulatory intelligence Dev...serp_jobs.internal_linking.show_more A company is looking for a Business Analyst - ARC (Accelerate Regulatory Capabilities) Submission Planning (Veeva Migration).
Key Responsibilities Collaborate with stakeholders to gather, validate...serp_jobs.internal_linking.show_more 
Ensure the development of appropriate regulatory strategies and their execution for assigned Vaccines asset(s) consistent with Medicines Development Strategy.
This goal has to be achieved both as a ...serp_jobs.internal_linking.show_more A company is looking for a Licensing Associate - Regulatory & International Licensing.Key Responsibilities Support the end-to-end process of obtaining and maintaining Money Transmitter Licenses (...serp_jobs.internal_linking.show_more A company is looking for a Sr Manager, Regulatory Affairs.Key Responsibilities Prepare and submit moderately complex regulatory submissions and documents for investigational and commercial produc...serp_jobs.internal_linking.show_more A company is looking for a Manager of Regulatory Affairs.Key Responsibilities Provide regulatory advice and manage various Regulatory Affairs activities Plan, prepare, coordinate, and submit reg...serp_jobs.internal_linking.show_more 
Biotech Business, Food Safety Regulation, and Regulatory Science.Advanced Academic Programs (AAP) is a division of the Krieger School of Arts and Sciences at the Johns Hopkins University (JHU).As t...serp_jobs.internal_linking.show_more
Senior Manager, Regulatory Affairs.Shape the Future of Vision Care with Euclid Vision Corporation!.Are you a regulatory affairs professional with a passion for medical device innovation? Do you thr...serp_jobs.internal_linking.show_more
Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health.
Our RNA medicines platform, PRISM, combines multiple modalities, ch...serp_jobs.internal_linking.show_more
Senior Director Of Regulatory Affairs.The Senior Director of Regulatory Affairs provides regulatory leadership and develops regulatory strategies for products in development to support clinical tri...serp_jobs.internal_linking.show_more A company is looking for a Head of Global Regulatory Affairs.Key Responsibilities Define and lead the global regulatory vision and strategy across all categories and geographies Oversee regulato...serp_jobs.internal_linking.show_more A company is looking for a Site Activation and Maintenance Associate I.Key Responsibilities Initiate and manage investigator site activities, including regulatory document collection and informed...serp_jobs.internal_linking.show_more 
Director, Regulatory Science And Policy.The Director, Regulatory Science and Policy, works closely with the Vice President, Science Policy and Government Affairs (and Chief Policy Officer) to imple...serp_jobs.internal_linking.show_more
Regulatory Science & Policy Director.The Regulatory Science & Policy Director is responsible for guiding the analysis of global regulatory requirements, policies and industry standards to identify ...serp_jobs.internal_linking.show_more
Responsibilities : Support the Senior Director in developing and executing regional regulatory strategies for QOL initiatives within specific regions.
Contribute to providing strategic oversight and ...serp_jobs.internal_linking.show_more
Regulatory Affairs Lead
VirtualVocations • Alexandria, Virginia, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
Regulatory Affairs Specialist
VirtualVocations • Rockville, Maryland, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Regulatory Affairs Manager
VirtualVocations • Baltimore, Maryland, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Senior Regulatory Affairs Specialist (Remote)
Pace Analytical Services, LLC • Frederick, MD, United States
serp_jobs.filters.remote
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Senior Consultant, Regulatory Affairs
John Staurulakis (jsitel.com) • Greenbelt, Maryland, US
serp_jobs.job_card.full_time
serp_jobs.filters_job_card.quick_apply
serp_jobs.last_updated.last_updated_30
US Regulatory Policy Director
VirtualVocations • Washington, District of Columbia, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Business Analyst - Regulatory Affairs
VirtualVocations • Alexandria, Virginia, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Director, Global Regulatory Affairs, Vaccines (Development and Life Cycle Management)
GSK • Rockville, MD, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Licensing Associate - Regulatory
VirtualVocations • Alexandria, Virginia, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Senior Regulatory Affairs Manager
VirtualVocations • Washington, District of Columbia, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
California Regulatory Affairs Manager
VirtualVocations • Alexandria, Virginia, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Adjunct Faculty : Division of Business and Regulation
InsideHigherEd • Baltimore, Maryland, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Senior Manager, Regulatory Affairs
Euclid • Sterling, VA, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Associate Director, Regulatory Affairs
Wave Life Sciences • Washington, DC, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Senior Director, Regulatory Affairs (Office or Remote)
Arcus Biosciences • Washington, DC, US
serp_jobs.filters.remote
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Global Regulatory Affairs Leader
VirtualVocations • Baltimore, Maryland, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Regulatory Specialist I
VirtualVocations • Alexandria, Virginia, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
Director, Regulatory Science and Policy
American Association for Cancer Research • Washington, DC, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Regulatory Science & Policy Director
Philips • Washington, DC, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Senior Regulatory Affairs Manager
Katalyst Healthcares & Life Sciences • Columbia, MD, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted