Regulatory Affairs Manager jobs in Irvine, CA

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PRINCIPAL SPECIALIST, REGULATORY AFFAIRS ADVERTISING & PROMOTION (ONSITE)

Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;. Making a difference in how we work and collaborate, constantly nurturing our nimble culture of inn...

CompanyAvanos Medical
AddressAlpharetta, GA
CategorySales/marketing
Salary401(k)
Date Posted 3 weeks ago See detail

Principal Specialist, Regulatory Affairs Advertising & Promotion (Onsite)

Avanos Medical

Alpharetta, GA

401(k)

Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;. Making a difference in how we work and collaborate, constantly nurturing our nimble culture of inn...

Regulatory Operations Submissions Manager - OneSource Regulatory

Onesource Regulatory

Chicago, IL

$105K - $133K a year

Regulatory Operations service provider to over 100 small to large sized companies Process Optimization. System Implementations. Document Management. Submission Management. Publishing. Archiving. RIM. Submission Managers. Publisher...

Regulatory Operations Project Manager - OneSource Regulatory

Onesource Regulatory

Chicago, IL

$102K - $129K a year

Regulatory Operations service provider to over 100 small to large sized companies Process Optimization. System Implementations. Document Management. Submission Management. Publishing. Archiving. RIM. Submission Managers. Publisher...

Quality & Regulatory Project Manager

Abbott Laboratories

Illinois, 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...

Clinical Affairs Senior Manager Immunossays

Biomérieux

United States

A family-owned company, bioMrieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve publi...

Regulatory Risk & Oversight Manager

Northern Trust

Chicago, IL

Unspecified

Responsible for supporting the definition and leading the execution against the identified pillars of the Program as a named Program Lead. Over time identifying and managing a small global team who will enable execution of the new...

Manager, Product Management- External Affairs - Richmond, United States - Capital One

Capital One

United States

Human CenteredYou'll lead sourcing and synthesis of customer discovery efforts to understand customer and user needs to drive the long-term vision for your product.You'll turn these customer insights into actionable strategies tha...

Sr. Manager Medical Affairs Strategy, PBC

Biospace

California, United States

Create, revise and maintain Medical Affairs slide decks.. Responsible for the development and execution of projects that will support and disseminate disease area background, medical questions or scientific data updates.. Serves a...

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...

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...

Sr Regulatory Affairs Specialist

Johnson & Johnson

Irvine, CA

...

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...

Senior Associate of Regulatory Affairs, CMC

Meitheal Pharmaceuticals Inc

Chicago, IL

Other duties may be assigned. Serves as the primary regulatory interface with global US FDA manufacturing partners , and internal teams to ensure the business needs for the assigned products are met by anticipating, identifying,...

Senior Regulatory Affairs Program Lead

Johnson & Johnson

Irvine, CA

...

AML Monitoring and Regulatory Manager - (M/F)

Axa

Delaware, United States

Assisting AXA entities in developing and enhancing their AML and targeted sanctions compliance programs, including policies, procedures, training programs, and monitoring processes. Providing accurate, timely, and consistent AML t...

Principal Regulatory Affairs Specialist (medlance.co)

Medlance

Remote

$30 - $300 an hour

Lead regulatory strategy development for medical device projects. Manage submissions to regulatory bodies. Advise on regulatory requirements and changes. Collaborate with cross-functional teams for regulatory compliance. Extensive...

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...

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...

Associate Director, Regulatory Affairs - West Chester, PA

Teva Pharmaceuticals

United States

Spearhead the delivery of successful investigational and regulatory license applications and product life cycle management submissions with the Global Regulatory Affairs Team from initial filing through post-approval management. P...

Regulatory Affairs Specialist II

Bausch + Lomb

Remote

$65,000 - $95,000 a year

Responsible for general knowledge of pharmaceutical, consumer and medical device regulations in Regional and Local markets. Partners closely with cross-functional stakeholders to document registration strategy and implementation p...

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...

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...

Senior Manager, US Medical Advertising and Promotions Regulatory (GI)

Biospace

Lexington, MA

I further attest that all information I submit in my employment application is true to the best of my knowledge.About the role:Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review, GI where you will be an interna...

Regulatory and Transaction Coding Manager

Wellsense Health Plan

Remote - Oregon, United States

Full-time remote work. Competitive salaries. Excellent benefits. Develops and maintains corporate transaction policies, and works collaboratively with stakeholders and department manager to ensure consistency with the Plans syste...

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...

Regulatory Risk & Oversight Manager

Northern Trust

Chicago, IL

Unspecified

Responsible for supporting the definition and leading the execution against the identified pillars of the Program as a named Program Lead. Over time identifying and managing a small global team who will enable execution of the new...

Manager, Regulatory Reporting

Northern Trust

Chicago, IL

Unspecified

Responsible for managing a Fund Administration group for Hedge Fund Services. Seasoned multi-disciplinary expert with extensive technical and / or business knowledge and functional expertise. Focus of role is on setting strategic...

Associate Director, Global Delivery Manager-Regulatory Operations

Biogen

Remote

$135,000 - $235,000 a year

Lead delivery of global submissions including oversight of coordination of US, EU, and BIR deliverables with vendor and US, EU, and BIR strategic plan. Create global submission dossier and ensure consistency and quality of submiss...