Full-Time Regulatory Affair Director jobs in California

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ASSOCIATE DIRECTOR, REGULATORY AFFAIRS ADVERTISING AND PROMOTION

Provides commercial regulatory support to high-volume brands or therapeutic area and projects without managerial oversight, as appropriate. Reviews and approves promotional materials.. Serves as PRC Chair for one or more high-volu...

CompanyBiospace
AddressCalifornia, United States
CategorySales/marketing
Job typeFull time
Date Posted 3 weeks ago See detail

Associate Director, Regulatory Affairs Advertising and Promotion

Biospace

California, United States

Provides commercial regulatory support to high-volume brands or therapeutic area and projects without managerial oversight, as appropriate. Reviews and approves promotional materials.. Serves as PRC Chair for one or more high-volu...

Director, Digital Health Regulatory Affairs

Mcra

West Virginia, United States

Develop and execute regulatory services for client companies, including however not limited to:. Regulatory Submissions (510(k), IDE, PMA, De Novos, BLA, & IND). Regulatory Strategy, Analysis & Development. Design, Review & Implem...

Director, CMC Regulatory Affairs Biologics

Biospace

California, United States

Lead CMC regulatory strategy for a single or multiple products. Lead the execution and influence the development of global CMC regulatory strategies, including risk mitigation strategies to ensure right first-time approvals of pro...

Director, Regulatory Affairs Advisor & Liaison

Capital One

Virginia, United States

Enjoy working with banking regulators Closely follow digital and technological developments in banking and financial services Understand and appreciate technology and cyber security risk management Relish interacting with senior l...

Manager, Global Regulatory Affairs CMC Submissions Management - Now Hiring

Takeda Pharmaceutical

New York, United States

$138,500 - $186,000 per year

I further attest that all information I submit in my employment application is true to the best of my knowledge.Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in...

Assoc. Director, Field Medical Affairs-Hematology (northern CA)

Biospace

United States

Territory: Northern CA, NevadaA typical day may include the following: Identifying and maintaining a list of relevant medical/therapeutic area experts, investigator targets and associated plans of action.Establishing, fostering, c...

Senior Manager, Regulatory Affairs Vendor Governance

Biospace

California, United States

Own initiatives and day to day responsibilities in support of vendor oversight within RA. Negotiation and problem solving between Gilead RA leads and Vendor resources. Able to gather information or assign tasks or activities for o...

Director, Policy Advocacy -State Alliances, Government Affairs

Biospace

California, United States

Maintain strong understanding and extensive knowledge of Government Affairs objectives and broader Gilead business. Support robust stakeholder mapping and continuously track policy priorities, perspectives, and positions among sta...

Sr. Specialist, Regulatory Affairs CMC

Biospace

United States

Prepare content of CMC documentation for large and small molecule product submissions to regulatory agencies (FDA/EMA), ensuring accuracy, completeness, and consistency with strategy. Review and edit final documents for regulatory...

US Medical Affairs Sr. Field Director - Liver Medical Sciences Central Region

Biospace

California, United States

Leads and manages a team of Liver MSLs in the assigned East region, and reports to the US Medical Affairs Executive Director in Liver Disease.. Oversees MSL scientific engagement activities to support compliant HCP interactions as...

Director Medical Affairs Strategy, PBC

Biospace

California, United States

Regular communication with the Gilead Medical Scientist Liaison (MSL) team to remain current on issues in the field (gather insights) and to provide medical education, support, and direction.. Conducts advisory boards to collect f...

Regulatory Affairs Manager - Now Hiring

Abbott Laboratories

Texas, United States

$95000 - $190000 per year

Develops sound global regulatory strategies for new and modified medical devices. Prepares robust regulatory applications to achieve departmental and organizational objectives. Creates, reviews and approves engineering changes. Pr...

Student Affairs Director of Assessment

Liberty University

Remote

Provide leadership for the planning, development, and implementation of the Division of Student Affairs assessment initiatives. Train and advise the Student Affairs Assessment Coordinators as it pertains to their specific assessme...

Senior Director, Cellular Therapy Patient & Professional Relations, Public Affairs

Biospace

California, United States

Serve as a strategic business partner and advisor to Commercial and R&D teams, leveraging advocacy expertise, business acumen and interpersonal skills to bring the voice of the patient to Kite's planning and programming. Manage ke...

Director of Communications and External Affairs

American Sociological Association

Washington, United States

Conceptualize, implement, and manage an integrated content development and dissemination strategy to reach audiences both internal and External to ASA and the discipline of sociology. Lead membership-facing communications activiti...

Assistant Director Academic Affairs - Houston, United States - UTHealth Houston

Uthealth Houston

United States

100% paid medical premiums for our fulltime employees. Generous time off (holidays, preventative leave day, both vacation and sick time all of which equates to around 3738 days per year). The longer you stay, the more vacation you...

Manager Regulatory Affairs

Philip Morris

Washington, United States

Were totally transforming our business and building our future on one clear purpose to deliver a smoke-free future.In late 2022, PMI acquired Swedish Match and its leading oral nicotine product portfolio. Monitors & facilitates...

Regulatory Affairs Manager

Freudenberg Group

Remote

$94.6K - $120K a year

Provide regulatory excellence to the organization and guide decision making Responsible to direct, coordinate and supervise activities of Regulatory Affairs staff. Establish project priorities, ensure resources are available and b...

Regulatory Affairs Specialist

Redbock- An Nes Fircroft Company

Remote

$70.9K - $89.8K a year

Prepare and maintain international submission dossiers. Prepare electronic pre-market and post-market regulatory submissions. Compile Technical Documentations for IVD medical devices. Monitor progress on project deliverables and p...

Regulatory Affairs Senior Consultant

Medenvoy Global Bv

Remote

From $100,000 a year

Reviewing and processing of serious incidents related of medical devices of customers. Supervision of field safety corrective actions performed by clients. Communication with competent authorities and clients. Addressing post mark...

Regulatory Affairs Specialist

Brs

Remote

$62.1K - $78.7K a year

Contractor shall have at least 5 years experience applying FDA research regulatory requirements within a research Regulatory Affairs program office. Work in preparing ones own research proposals and ones own submissions to an IR...

Regulatory Affairs Manager - Electrophysiology

Abbott Laboratories

Minnesota, United States

$95,000 - $190,000 a year

Career development with an international company where you can grow the career you dream of. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO An excellent retirement savings plan with high employer con...

Senior Manager, Regulatory Affairs, CMC

Beigene

Remote

$133,400 - $178,400 a year

Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high- quality global submissions for investigational, market, and post-appro...

Sr. Manager, Regulatory Affairs CMC (Remote)

Ptc Therapeutics

Remote

Leads and manages the development of Module 2 and 3 CMC documents for regulatory filings such as INDs/IMPDs/CTAs and MAAs/NDAs/ global registrations and eCTD submissions, ensuring that they meet current regulatory standards and ar...

Regional Manager of Quality & Regulatory Affairs

Alaska Dialysis

Alaska, United States

$81.7K - $103K a year

Responsible for overseeing regulatory and growth perspective in accordance with Company goals. Assist in clinical operational development and transition of new or acquired clinic(s) as needed or requested. Assess and integrate cli...

Senior Regulatory Affairs Advisor

Cook Device Solutions

Remote

$100,000 - $125,000 a year

Authors submissions and other regulatory documents to obtain approval to bring new or modified products to market, including but not limited to FDA 510(k) submissions and EU MDR Technical Files. Manages communications with regulat...

Associate Director, Global Regulatory Project Management and Strategic Planning - Neuroscience

Biospace

Remote

As Associate Director, Global Regulatory Project Management and Strategic Planning, you will partner with the program Global Regulatory Lead (GRL), co-lead and facilitate product-specific Global Regulatory Team (GRT) meetings and...

Senior Director– Global Medical Affairs, Lilly Diabetes and Obesity

Biospace

Remote - Indiana, United States

Specific activities include developing or contributing to the global and/or regional clinical/medical plan in his/her therapeutic area of responsibility, the development, conduct and reporting of local clinical trials; the implem...

Medical Director, Global Medical Affairs (Neurology)

Ultragenyx Pharmaceutical

Remote - Oregon, United States

Develop and lead the neurology therapeutic medical strategy for the assigned therapeutic programs.. Develop and lead the integrated evidence generating plan for the neurology therapeutic programs.. Lead execution of the relevant...

Associate Director, Global Medical Affairs Phase 4 Research in HIV Treatment

Biospace

California, United States

Lead and support GMA-led Phase 4 Research studies in HIV Treatment, specifically for B/F/TAF data generation priorities related to the IRA submission, and as articulated through Gilead strategy documents [BVY indication strategic...