Full-Time Regulatory Affair Associate jobs in California

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ASSOCIATE DIRECTOR, REGULATORY AFFAIRS INNOVATION

Leads and/or supports medical device / pharma development, including Clinical Outcome Assessment tools and Digital Health Technologies, and global filing activities from a regulatory standpoint from initial product concept through...

CompanyBiospace
AddressIrvine, CA
CategoryInformation Technology
Job typeFull time
Date Posted 8 hours ago See detail

Associate Director, Regulatory Affairs Innovation New

Biospace

Irvine, CA

Leads and/or supports medical device / pharma development, including Clinical Outcome Assessment tools and Digital Health Technologies, and global filing activities from a regulatory standpoint from initial product concept through...

Associate Director, Regulatory Affairs

Biospace

San Rafael, CA

Lead the development, integration, execution and maintenance of the global nonclinical and clinical regulatory strategy for the Global Regulatory Plan (GRP) throughout the product lifecycle. Ensure strategic alignment with the Cli...

Counsel, Head of Global Regulatory Affairs

An Asset Management Company

Los Angeles, CA

Coordinate TCW's engagement with regulators and other policymakers on Global Regulatory matters, including representing TCW in such engagements. Position TCW to influence policy and regulations; consider TCW's clients and business...

Sr. Director, Regulatory Affairs

Biospace

San Diego, CA

Develop, implement and maintain regulatory and quality assurance strategies and activities for AnaptysBios pipeline programs. Serve as the FDA contact, leading creative and constructive interactions with regulatory agencies...

Director, Regulatory Affairs, Oncology - Job ID: 1311

Ascendis Pharma

Palo Alto, CA

Medical insurance. Vision insurance. Dental insurance. 401(k). Paid maternity leave. Paid paternity leave. Commuter benefits. Disability insurance. Life Insurance (Basic, Voluntary & AD&D)....

Director, Clinical Regulatory Affairs

Cymabay Therapeutics

Newark, CA

Work with Vice President to devise regulatory strategies to ensure rapid and timely approval of products. Develop global regulatory plans to facilitate the progress of programs in all phases of development. Identify risk mitigatio...

Certification and Licensing Coordinator, Regulatory Affairs, Full time, Days

Pih Health

Los Angeles, CA

Effective written/oral communication, and presentation skills. Problem-solving skills. Strong knowledge of performance improvement tools and techniques. Proficient computer literacy. California RN License. Bachelors Degree in hea...

Associate Director Regulatory Labeling

Acadia Pharmaceuticals Inc.

San Diego, CA

Support with developing draft labeling text (e.g. USPI, PPI, Med Guide, EU SmPC, EUPIL) to support marketing applications and labeling update of approved package inserts to support product lifecycle management. Support implementat...

Head/ Sr Director of Global Regulatory Affairs

Predicine, Inc

Hayward, CA

Responsible for setting strategy and leading the Predicine Global Regulatory Affairs organization. Organize and oversee the preparation, review, and submission of regulatory documents to regulatory authorities for In vitro diagnos...

Vice President Regulatory Affairs, Obesity

Biospace

Thousand Oaks, CA

Develops the vision of the Regulatory Therapeutic Area for Obesity and Obesity Related Conditions (ORCs) and drives its execution, ensuring the globalization of strategy and process. Represents the Regulatory Affairs Therapeutic A...

Regulatory Affairs Specialist

Argen Corporation

San Diego, CA

Argen is a global leader in dental manufacturing with headquarters in San Diego, CA, subsidiaries in Canada, Germany, UK, and China, and sales in 105 countries worldwide. Our Awesome Benefits!Working for a growing innovative compa...

Regulatory Affairs Senior Program Manager

Biospace

San Francisco, CA

6+ years of Regulatory Affairs experience in the biopharmaceutical industry or equivalent Pref Knowledge of regulatory requirements and early to mid-clinical stage experience with US regulatory submissions for therapeutic products...

Director, Regulatory Affairs

Biospace

San Diego, CA

Accountable for the development and implementation of the regulatory strategy for AnaptysBios pipeline programs. Serve as the FDA contact, leading creative and constructive interactions with regulatory agencies to effectively neg...

Sr. Manager of Regulatory Affairs/ In-House Counsel at Software Company

Alchemy Legal

Los Angeles, CA

Lead and manage collections efforts, including developing strategies, negotiating settlements, and overseeing litigation processes. Handle litigation matters, including case management, legal research, and representation in legal...

Principal Regulatory Affairs Specialist

Vertos Medical, Inc

Aliso Viejo, CA

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Mental Demand Moderate to high degree of concentration due to volume, complexity, and/or pressure of work. Abil...

Staff/Principal Regulatory Affairs Specialist (Operations)

Recor Medical

Palo Alto, CA

Manages post market activities, including but not limited to EU MDR and MEDDEV compliant Clinical Evaluation documents for new products and maintain/update existing company Clinical Evaluation Plans (CEPs), Clinical Evaluation Rep...

Executive Director, Regulatory Affairs

Biospace

San Diego, CA

Set strategy, direct, plan and implement clinical regulatory activities required to initiate and conduct clinical trials and to seek marketing authorization. Interact with the FDA, EMA, PMDA, and other regulatory agencies to seek...

VP/Senior VP, Regulatory Affairs

Biospace

San Diego, CA

Set strategy, direct, plan and implement clinical regulatory activities required to initiate and conduct clinical trials and to seek marketing authorization. Interact with the FDA, EMA, PMDA, and other regulatory agencies to seek...

Sr. Director, Regulatory Affairs Strategy

Taiho Oncology, Inc.

Pleasanton, CA

$240,000 - $283,000 a year

Responsible to represent the Regulatory Affairs position and decision in assigned Project Teams, due diligence assessments, and compliance remediations for Taiho Oncology, Inc., (TOI), projects including exploratory development an...

Regulatory Affairs Manager (Medical Device/Cosmetic) - Long Beach, California (Hybrid)

Beautyhealth

Long Beach, CA

$130,000 - $150,000 a year

Lead all Regulatory Affairs projects to ensure compliance with all international, federal, state, and local facility/product registration, licensing, and reporting requirements for cosmetics and medical devices. Support in managin...

Regulatory Affairs Project Manager

Endologix

Irvine, CA

$104,000 - $165,000 a year

Represent RA department in assigned project meetings and provide regulatory guidance to ensure adherence with global regulatory requirements as appropriate. Maintain up-to-date knowledge on domestic and international regulatory re...

Manager, Regulatory Affairs

Ascendis Pharma

Palo Alto, CA

$140,000 - $150,000 a year

Today, were advancing programs in Endocrinology Rare Disease, Oncology, and Ophthalmology.We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful diffe...

Sr. Manager, Regulatory Affairs GMP

Ajinomoto Bio-Pharma Services

San Diego, CA

Leads all aspects of Regulatory Affairs for manufacture of commercial and clinical parenteral medicines according to approved protocols, regulations, and schedules. Provides best in class regulatory strategy and guidance for inter...

REGULATORY ASSOCIATE I/II

Adicet Bio

Redwood City, CA

Bachelors degree in life sciences or a relevant field in an advanced degree preferred. 2-5 years working within the biotech/pharmaceutical industry. 1+ years of experience in regulatory affairs preferred. Prior experience with ce...

Marine Regulatory Affairs Manager

Yamaha

Cypress, CA

Interact directly with regulators and lawmakers when appropriate and with the guidance of Yamahas management and when possible, in coordination with NMMA. Develop strong relationships with the National Marine Manufacturers Associ...

Associate Regulatory Compliance Analyst

Northrop Grumman

Redondo Beach, CA

Category: Legal and Regulatory Location: Melbourne, Florida, United States of America | Redondo Beach, California, United States of America | Unknown, Virginia, United States of America+ 2 more Citizenship required: United States...

Associate Vice President, Faculty Affairs

California State University

Pomona, CA

Required Visa Status:CitizenGCUS CitizenStudent VisaH1BCPTOPTH4 Spouse of H1BGC Green CardEmployment Type:Full TimePart TimePermanentIndependent - 1099Contract W2C2H IndependentC2H W2Contract Corp 2 CorpContract to Hire Corp...

Associate Director, CMC Regulatory

Cargo Therapeutics

San Carlos, CA

Represent Regulatory CMC on cross-functional teams to help progress CARGOs cell-based gene therapy pipeline. Proactively identify and communicate risks and propose solutions to complex regulatory CMC issues. Develop comprehen...