Regulatory Affair Manager jobs in Chicago, IL

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MANAGER, GLOBAL REGULATORY AFFAIRS CMC SUBMISSIONS MANAGEMENT

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...

CompanyBiospace
AddressLexington, MA
CategoryInformation Technology
Job typeFull time
Date Posted 3 days ago See detail

Manager, Global Regulatory Affairs CMC Submissions Management

Biospace

Lexington, MA

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...

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...

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...

Senior Manager, Global Regulatory Labeling Strategy

Biospace

Remote

Leads Labeling cross-functional teams, facilitates discussions on labeling strategies and content for assigned product(s) and ensures cross-functional collaboration and alignment, for assigned product(s), with appropriate supervis...

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...

Senior Manager/Associate Director of Regulatory Affairs

Tempus

Chicago, IL

Developing and leading global regulatory strategies to support business objectives. Leading submissions and correspondence with global regulatory authorities, including 510(k),PMA, De Novo authorizations, IDE, MDR CE marking, UKCA...

Manager, Regulatory Affairs

Invenergy

Chicago, IL

Monitor, coordinate and lead advocacy efforts at state economic and environmental regulatory bodies (public utility commissions, public service commissions, utility boards, state procurement entities, state EPA or siting authoriti...

Manager - Regulatory Affairs

Biospace

Lexington, MA

Compile, submit and maintain applications (IND, CTAs, NDAs etc.) to regulatory agencies in support of investigational and marketed products, including compiling and submitting responses to agency queries. Create and maintain produ...

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...

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 as...

Regulatory Affairs Specialist III

Boston Scientific

Maple Grove, MN

Under direct supervision of the RA Project Manager, or Department Manager, assists in preparing moderately complex submissions to gain approvals for clinical research, export, and commercial distribution, such as: IDE, IDES, IDE...

Manager External Affairs, US Southeast

Philip Morris

Washington, United States

So, wherever you join us, youll enjoy the freedom to dream up and deliver better, brighter solutions and the space to move your career forward in endlessly different directions.External Affairs is a growing team, full of fresh op...

Manager Federal Government Affairs

Philip Morris

Washington, United States

Our success depends on people who are committed to our purpose and have an appetite for progress.We are currently seeking a Manager of Federal Government Affairs to join our team in Washington, D.C. and play an active role in the...

Manager, Risk & Regulatory Advisory

Morgan Franklin

California, United States

Work with emerging growth companies and established enterprises (bothpubliclytraded and privately held) on a wide variety of projects including Sarbanes-Oxley ("SOX") readiness and compliance, internal audit, and ERM.. Assist c...

Senior Manager, Risk & Regulatory Advisory

Morgan Franklin

Texas, United States

Work with emerging growth companies and established enterprises (bothpubliclytraded and privately held) on a wide variety of projects including Sarbanes-Oxley ("SOX") readiness and compliance, internal audit, and ERM.. Assist...

Manager, Risk & Regulatory Advisory

Morgan Franklin

Texas, United States

Work with emerging growth companies and established enterprises (bothpubliclytraded and privately held) on a wide variety of projects including Sarbanes-Oxley ("SOX") readiness and compliance, internal audit, and ERM.. Assist c...

Regulatory Affairs Specialist

Convatec

Lexington, MA

$49.4K - $62.5K a year

Directing submission development of product registration, progress reports, supplements, amendments, and/or periodic experience reports Providing strategic product direction to teams on interaction and negotiating evidence with re...

Associate Director, Regulatory Affairs Innovation

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...

Regulatory Affairs Associate - North Chicago, United States - Validation Associates

Validation Associates

United States

As the professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration in EURI/MENAP global. Individual shall develop partnership...

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...

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...

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...