Staff Regulatory Affairs jobs

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MANAGER, REGULATORY AFFAIRS - BIOSENSE WEBSTER, INC.

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CompanyJohnson & Johnson
AddressIrvine, CA
CategoryInformation Technology
Date Posted 2 months ago See detail

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...

Banking Regulatory Affairs, Assistant Vice President

Pix11

New York, NY

Background in regulatory relations and knowledge of heightened regulatory environment. Manage the standing MIS regulatory request process and submit all requested MIS to regulators. Provide support to RAO Team Leaders on regulator...

Senior Manager, Regulatory Affairs - Proliant Health & Biologicals

Lauridsen Group, Inc.

Ankeny, IA

Professional conduct with high attention to detail. Strong verbal and written communication skills. Ability to work collaboratively and coordinate with team members. Competence in multitasking and organizational methods. Self-star...

Regulatory Affairs Associate - Drug Products (Princeton, NJ (USA), US)

Laboratoire Guerbet

Princeton, NJ

Participate in pre-submission meetings with FDA in order to agree on potential regulatory pathways, clarification and follow-up of submissions under review. Coordinate preparation, review, submission of e-CTD regulatory dossiers t...

Director, Precision Medicine and Digital Health - Global Regulatory Affairs

Takeda Pharmaceuticals

Boise, ID

You will also establish effective collaborations with the various groups and leadership involved in the development and commercialization of biomarkers, diagnostic tests, and Digital tools to ensure goals/objectives are met. + Und...

Director, Regulatory Affairs - Pharmaceuticals

Stryker

Mahwah, NJ

Serves as member of the extended business unit leadership team. Able to effectively communicate, interact, and navigate issues at leadership level. Creates long term regulatory strategy for drug products, provides input on combina...

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, Regulatory Affairs - Advertising, Promotion and Regulatory Compliance

Ferring Pharmaceuticals

Parsippany, NJ

Manage Regulatory Affairs, Advertising & Promotion and Compliance GroupManage the US RA Ad Promo, submission operations, labeling and compliance group staff, including objective setting and career development activities and motiva...

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,...

VP, Legal - Regulatory Affairs

A Biotechnology Company

Washington, DC

Working directly with clients, provide strategic and practical legal counsel on a wide variety of drug and medical device development legal and regulatory issues. As a strategic partner, work to identify and advise on business and...

Senior Manager Regional Regulatory Affairs

Biospace

King Of Prussia, PA

You will be the primary CSL representative to regional health authorities for assigned products.. Develop the establishment and maintenance of high quality relationships with regional health authorities and collaborating with resp...

2024 Summer Intern -Regulatory Affairs

Colgate-Palmolive

Topeka, KS

Must be current student, in good academic standing, post-second year or higher, and seeking a degree in Grain or Feed Science, Animal or Veterinary Science, Animal Nutrition, Biology, or Business Analytics/ Information Systems. M...

Sr. Regulatory Affairs Specialist - Cardiac Diagnostics CDx

Boston Scientific

Hills, MN

Supports the development of domestic and international strategies for regulatory approval of Class I, II and III medical devices. Coordinates, compiles, and submits U.S. and EU regulatory filings for new and modified products, inc...

Staff Accountant III - Regulatory Reporting

Bankunited

Lorida, FL

Compiles financial information, account analyses and financial disclosures or reports. Records, classifies, and summarizes financial transactions in accordance with Company policy and Generally Accepted Accounting Principles. Keep...

Staff Accountant III - Regulatory Reporting

Bankunited Financial Corporation

Lorida, FL

Preparing or processing journal entries, reconciling accounts and providing financial data to business partners and management are also required functions. Records, classifies, and summarizes financial transactions in accordance w...

Staff Environmental Regulatory Permitting Specialist - High Speed Rail

Arcadis

San Francisco, CA

Biological Oversight regulatory compliance and report monitoring under California Environmental Quality Act/ National Environmental Policy Act (CEQA/NEPA), Federal Endangered Species Act Permitting (Biological Opinion), California...

Staff Counselor (I,II,III) Embedded with International Affairs

Southern Utah University

Cedar City, UT

Provide time-limited counseling services, consultation, clinical assessment and triage services, some limited case management, and crisis interventions for the international student population. Prepare for sessions and maintain ac...

Senior Staff Representative - Regulatory Compliance & Dangerous Goods

United Airlines, Inc.

Chicago, IL

Facilitates designated aspects of United's end-to-end Voluntary Disclosure program components to ensure adherence to regulatory requirements and timelines. Partners with the divisions to capture corrective actions in areas found n...

Counsel Senior Manager - Legal Entity Governance: Public, Regulatory and Corporate Affairs

Wells Fargo

Charlotte, NC

Work on matters for the subsidiaries of Wells Fargo & Company, including support for all aspects of Legal Entity corporate governance, planning and preparing for board and committee meetings, overseeing board evaluations for subsi...