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REGULATORY AFFAIRS ASSOCIATE - DRUG PRODUCTS (PRINCETON, NJ (USA), US)

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...

CompanyLaboratoire Guerbet
AddressPrinceton, NJ
CategoryInformation Technology
Job typeFull-Time
Date Posted 3 weeks ago See detail

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...

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,...

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...

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...

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...

Manager, Regulatory Affairs CMC

Pix11

New York, NY

The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, c...

Senior Regulatory Affairs Program Lead

Johnson & Johnson

Raynham, MA

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Senior Regulatory Affairs Program Lead

Johnson & Johnson

Irvine, CA

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Manager, Regulatory Affairs CMC - Now Hiring

Takeda Pharmaceutical

Bronx, NY

The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, c...

Manager, Regulatory Affairs CMC

Biospace

Boston, 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 in Cambridge, MA with the...

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...

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...

Regulatory Affairs Analyst

Brycetech

Washington, DC

CBRN Research and Analysis. CBRN Policy and Doctrine Support. Special Projects. Policy support to the Federal Radiological Preparedness Coordinating Committee (FRPCC). Planning support to the Chemical, Biological, Radiological/Nuc...

Sr. Project-Program Manager, Regulatory Affairs

Arthrex

Naples, FL

Manages subsidiary-based and global projects/programs within the scope of the Regulatory Affairs.. Develops project objectives by reviewing project proposals and business plans, conferring with senior management and key stakeholde...

Regulatory Affairs Manager Regional Regulatory Lead

Biospace

Washington, DC

Implement the US regulatory plan and obtain and maintain Clinical Trial Authorizations and Marketing Application approvals in the US. Provide content for and coordinate US regulatory documents and meetings in accordance with GRT s...

SVP, Global Regulatory Affairs

Biospace

Waltham, MA

Ensure the development, preparation, and implementation of global strategic regulatory plan for all programs and product pipeline designed to maximize successful and expedient global product registrations. Responsible for managing...

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...

Manager, Regulatory Affairs CMC - Now Hiring

Takeda Pharmaceutical

Brooklyn, NY

The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, c...

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...

Licensing & Regulatory Affairs Analyst

Sportradar

Las Vegas, NV

Tracking sports betting and iGaming legislative and regulatory efforts of new and existing jurisdictions with special focus on licensing requirements. Research, populate, and maintain internal library of country specific regulator...

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...

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...