Talent.com
Regulatory Affairs Lead
Regulatory Affairs LeadVirtualVocations • Escondido, California, United States
Regulatory Affairs Lead

Regulatory Affairs Lead

VirtualVocations • Escondido, California, United States
job_description.job_card.variable_hours_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 • Escondido, California, United States

Job_description.internal_linking.related_jobs
Manager, Regulatory Affairs - Hybrid - 134458

Manager, Regulatory Affairs - Hybrid - 134458

UC San Diego • San Diego, CA, United States
serp_jobs.job_card.full_time
Health Sciences Drive, San Diego, CA 92093, United States .Manager, Regulatory Affairs - Hybrid.Extended Deadline : Mon 10 / 20 / 2025. UC San Diego values and welcomes people from all backgrounds.If you...serp_jobs.internal_linking.show_more
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Senior Manager of Regulatory Affairs (CMC)

Senior Manager of Regulatory Affairs (CMC)

EPM Scientific • San Diego, CA, United States
serp_jobs.job_card.full_time
Senior Manager, Regulatory Affairs CMC.The Senior Manager of Regulatory Affairs CMC will be responsible for managing, evaluating, and completing regulatory projects aligned with company objectives....serp_jobs.internal_linking.show_more
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
RayzeBio Director of Regulatory Affairs - Clinical / NonClinical

RayzeBio Director of Regulatory Affairs - Clinical / NonClinical

Bristol Myers Squibb • San Diego, CA, US
serp_jobs.job_card.full_time
We are seeking an experienced and innovative Director in Regulatory Affairs (clinical and nonclinical).This Global Regulatory Lead (GRL) position will report to the Head of Regulatory Affairs and w...serp_jobs.internal_linking.show_more
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Sr. Regulatory Affairs Manager

Sr. Regulatory Affairs Manager

Katalyst Healthcares & Life Sciences • San Diego, CA, US
serp_jobs.job_card.full_time
Responsibilities : The Regulatory Manager provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, pediatric pla...serp_jobs.internal_linking.show_more
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Associate Director Regulatory Affairs

Associate Director Regulatory Affairs

Abbott • San Diego, CA, United States
serp_jobs.job_card.full_time
Abbott is a global healthcare leader that helps people live more fully at all stages of life.Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses an...serp_jobs.internal_linking.show_more
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Senior Manager Global Regulatory Affairs

Senior Manager Global Regulatory Affairs

EPM Scientific • San Diego, CA, United States
serp_jobs.job_card.full_time
A clinical stage biotech organization is seeking a.Manager / Senior Manager Regulatory Affairs.This company is pioneering RNA interference-based therapeutics to address serious diseases with high unm...serp_jobs.internal_linking.show_more
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Manager, Regulatory Affairs - Hybrid - 134458

Manager, Regulatory Affairs - Hybrid - 134458

UC San Diego Health • San Diego, CA, United States
serp_jobs.job_card.full_time
This position will remain open until a successful candidate has been identified.Eligible Special Selection clients should contact their Disability Counselor for assistance.This position will work a...serp_jobs.internal_linking.show_more
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Director, Regulatory Affairs - Gene Therapy

Director, Regulatory Affairs - Gene Therapy

Insmed • San Diego, CA, US
serp_jobs.job_card.full_time
The Director, Regulatory Affairs will serve as the regulatory leader on cross-functional teams, where they will be responsible for guiding strategy, identifying risks, interpreting regulations and ...serp_jobs.internal_linking.show_more
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Regulatory Affairs Manager (San Diego)

Regulatory Affairs Manager (San Diego)

CorDx • San Diego, CA, US
serp_jobs.job_card.full_time
CorDx, a multi-national biotech organization focused on pushing the limits of innovation and supply in global health, delivers rapid testing and point-of-care medical device solutions used in the d...serp_jobs.internal_linking.show_more
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Director Quality Assurance Regulatory Affairs

Director Quality Assurance Regulatory Affairs

BioTalent • Carlsbad, CA, United States
serp_jobs.job_card.full_time
Director of Quality & Regulatory Affairs – Medical Devices.Location : North San Diego | 💼 Full-time | 🏥 Medical Device Industry. We are seeking a Director of Quality & Regulatory Affairs to provide...serp_jobs.internal_linking.show_more
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Senior Manager of Regulatory Affairs (CMC) (San Diego)

Senior Manager of Regulatory Affairs (CMC) (San Diego)

EPM Scientific • San Diego, CA, US
serp_jobs.job_card.part_time
Senior Manager, Regulatory Affairs CMC.The Senior Manager of Regulatory Affairs CMC will be responsible for managing, evaluating, and completing regulatory projects aligned with company objectives....serp_jobs.internal_linking.show_more
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Senior Manager Global Regulatory Affairs (San Diego)

Senior Manager Global Regulatory Affairs (San Diego)

EPM Scientific • San Diego, CA, US
serp_jobs.job_card.part_time
A clinical stage biotech organization is seeking a.Manager / Senior Manager Regulatory Affairs.This company is pioneering RNA interference-based therapeutics to address serious diseases with high unm...serp_jobs.internal_linking.show_more
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Regulatory Affairs Specialist II

Regulatory Affairs Specialist II

Katalyst Healthcares & Life Sciences • San Diego, CA, US
serp_jobs.job_card.full_time
Responsibilities : This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U. Europe, support of international product registrations ...serp_jobs.internal_linking.show_more
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Staff Regulatory Affairs Specialist

Staff Regulatory Affairs Specialist

Becton Dickinson • San Diego, CA, US
serp_jobs.job_card.full_time
The Staff RA Specialist will represent Regulatory Affairs within the Worldwide Infusion Preparation and Delivery (WWIPD) platform on compliance projects, product engineering, new product developmen...serp_jobs.internal_linking.show_more
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Associate Director Regulatory Affairs - Becton Dickinson

Associate Director Regulatory Affairs - Becton Dickinson

BD • San Diego, CA, United States
serp_jobs.job_card.full_time
Associate Director Regulatory Affairs (Hybrid) - Becton Dickinson.Associate Director Regulatory Affairs (Hybrid) - Becton Dickinson. Associate Director Regulatory Affairs (Hybrid) - Becton Dickinson...serp_jobs.internal_linking.show_more
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Associate Director Regulatory Affairs

Associate Director Regulatory Affairs

Abbott Laboratories • San Diego, CA, United States
serp_jobs.job_card.full_time
Abbott is a global healthcare leader that helps people live more fully at all stages of life.Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses an...serp_jobs.internal_linking.show_more
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Manager, Regulatory Affairs - Hybrid - 134458

Manager, Regulatory Affairs - Hybrid - 134458

University of California San Diego • San Diego, CA, United States
serp_jobs.job_card.full_time
CANCER CENTER / Clinical Trials Office.Days, 8 hrs / day, Monday-Friday.Manager, Regulatory Affairs - Hybrid.Extended Deadline : Tue 9 / 2 / 2025. UC San Diego values equity, diversity, and inclusion.If you ...serp_jobs.internal_linking.show_more
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Regulatory Affairs Specialist

Regulatory Affairs Specialist

Aequor • San Diego, CA, US
serp_jobs.job_card.full_time
Scope Of Responsibilities : He / She will be responsible for representing regulatory function to approve promotional material He / She will be at ease working in a matrix environment and be able to na...serp_jobs.internal_linking.show_more
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Senior Director Regulatory Affairs, Dispensing

Senior Director Regulatory Affairs, Dispensing

Becton Dickinson • San Diego, CA, US
serp_jobs.job_card.full_time
BD is one of the largest global medical technology companies in the world.Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of usfrom ...serp_jobs.internal_linking.show_more
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Regulatory Affairs Director

Regulatory Affairs Director

Truvian • San Diego, CA, US
serp_jobs.job_card.full_time
Truvian is seeking an experienced and hands-on Regulatory Affairs Director to lead and execute all aspects of the company's global regulatory strategy. This leadership role will be responsible for s...serp_jobs.internal_linking.show_more
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted