Regulatory Affair Director jobs in California

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SR. DIRECTOR, REGULATORY AFFAIRS

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...

CompanyBiospace
AddressSan Diego, CA
CategoryInformation Technology
Job typeFull time
Date Posted a week ago See detail

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...

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...

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...

Director of Student Affairs/Stdt Svc Mgr 1

Uc Davis Health

Sacramento, CA

Provide direct support to the Associate Dean for Students in conducting data analyses, supporting and leading committee meetings, policy development, and completing annual reports and surveys. Provide 1:1 case management (and/or g...

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...

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...

Associate Director, Regulatory Affairs

American Cybersystems

San Rafael, CA

One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022). ClearlyRated Client Diamond Award Winner (2020). One of the Largest Certified MBE Companies in the NMSDC Network...

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...

Senior Director, Regulatory Affairs

Alx Oncology Inc.

South San Francisco, CA

Providing dynamic regulatory leadership and guidance to project teams and working collaboratively with cross-functional team members, external contractors, vendors and consultants to identify optimum and effective regulatory strat...

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 Regulatory Affairs Specialist

Johnson & Johnson

Irvine, CA

...

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...

Corporate Affairs Director, Research

Amgen

Thousand Oaks, CA

Degree in public relations, communications or journalism experience working in-house or within a PR agency Biotechnology, pharmaceutical or healthcare product public relations including corporate experience highly desired Hands on...

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 Policy and Intelligence Director

Biospace

Thousand Oaks, CA

Masters a range of regulatory and R&D policy topics as assigned and provides strategic regulatory and R&D policy advice and guidance on a range of issues related to Amgens product portfolio. Monitors, analyzes, and anticipates cha...

DIRECTOR OF NURSING AFFAIRS, DEPARTMENT OF HEALTH SERVICES (UC)

County Of Los Angeles

Los Angeles, CA

Please apply according to instructions located in the brochure:To download the brochure, click here. To view and print a copy of the brochure, you must have Adobe Acrobat Reader installed on your computer. Employment Type: Full ti...

Director of Clinical Affairs, Fluorescence Imaging

Intuitive

Sunnyvale, CA

This role will report to the VP & Business Leader of Intuitive Fluorescence Imaging. The role will assume leadership of the company's clinical, operational, and scientific strategies for clinical studies to support pre-market subm...

Associate Director of Student Affairs

Iec Corp Group

Stockton, CA

Complying with applicable federal and state laws and regulations, accreditor standards, and institutional policies and procedures;. Supervising, Monitoring and implementing student activities: Ensuring complete facilitation of Gat...

Director, Quality Assurance & Regulatory Affa

Denmat Holdings, Llc

Lompoc, CA

Coordinate activities in Quality Assurance, product returns, and regulatory to ensure compliance with all applicable regulatory requirements and achievement of company objectives as well as resolve problems; work with other depart...

Director of Legal Affairs

Visby Medical, Inc.

San Jose, CA

Risk Management and Legal Strategy: Proactively identify and calibrate legal risks and offer practical and creative solutions in alignment with the companys business goals and objectives. Commercial Support: Supporting the Sales...

Director, Medical Affairs (Conferences and Advocacy)

Kyverna Therapeutics

Emeryville, CA

Responsible for planning and logistical support for major conferences, Clinical and Medical team meetings, advisory boards, and other key HCP meetings. With the cross-functional team, responsible for short- and long-range strategi...

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...

Senior Regulatory Affairs Program Lead

Johnson & Johnson

Irvine, CA

...

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...