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Regulatory Affairs Manager jobs in Bridgewater, NJ

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USA REGULATORY AFFAIRS SPECIALIST PROJECT LEAD I SCIENTIFIC

Adecco Medical & Science is hiring a remote contract Regulatory Affairs Team Lead for our Pharmaceutical partner based out of Bridgewater, NJ.The anticipated wage for this position is between $88 and $89.22. A possible meeting in...

CompanyAdecco
AddressBridgewater, NJ
CategoryInformation Technology
Salary$ 88 - $ 89.22 / Hour
Job typeContract/Temporary
Date Posted 2 weeks ago See detail

USA Regulatory Affairs Specialist Project Lead I Scientific

Adecco

Bridgewater, NJ

$ 88 - $ 89.22 / Hour

Adecco Medical & Science is hiring a remote contract Regulatory Affairs Team Lead for our Pharmaceutical partner based out of Bridgewater, NJ.The anticipated wage for this position is between $88 and $89.22. A possible meeting in...

2 weeks ago seen See more...

Manager - Regulatory Affairs - Therapeutic Area

Biospace

Plainsboro, NJ

Compile and submit responses to FDA communications. MANAGER, THERAPEUTIC AREA: Compile, submit and maintain applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products. Create an...

3 days ago seen See more...

Associate Director, Regulatory Affairs

Bausch + Lomb

Bridgewater, NJ

Provide Regulatory support and guidance in the development, revision, review, and approval of labeling artwork for Health Authorities submissions, as well as any post marketing labeling changes. Responsible for post approval lifec...

2 months ago seen See more...

Associate Manager, Regulatory Affairs

Kenvue

Skillman, NJ

Understand the Regulatory landscape for Consumer products and effectively manage regulatory priorities and timelines for marketed products and will support regulatory strategy for innovative projects across many regulatory classif...

2 months ago seen See more...

Associate Manager, Regulatory Affairs

Johnson & Johnson Consumer Inc.

Skillman, NJ

Understand the Regulatory landscape for Consumer products and effectively manage regulatory priorities and timelines for marketed products and will support regulatory strategy for innovative projects across many regulatory classif...

2 months ago seen See more...

Manager Regulatory Operations

Biospace

Bridgewater, NJ

Support regulatory submission activities associated with generating electronic submissions in support of IND/NDA applications. Responsible for the archival of submission and submission related documents in the EDMS. Contribute to...

2 months ago seen See more...

Director, Regulatory Affairs Strategy - Genetic Medicine

Biospace

Basking Ridge, NJ

Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...

3 weeks ago seen See more...

Associate Director, Regulatory Affairs - Inflammation & Immunology

Biospace

Basking Ridge, NJ

Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...

3 weeks ago seen See more...

Associate Director, Regulatory Affairs

Johnson And Johnson

Somerville, NJ

Bring innovative regulatory approaches, deeply rooted in science, to lead the team in discussions with FDA and Health Canada to find the best development strategies for novel therapies in the areas where no other precedents exist....

2 months ago seen See more...

Director, Regulatory Affairs Strategy, Hematology

Biospace

Basking Ridge, NJ

Provide interpretation of regulatory authorities feedback, policies and guidelines. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...

4 weeks ago seen See more...

Director, Global Regulatory Affairs (GRL)

Biospace

Basking Ridge, NJ

Manages, directs, and drives the strategy for all Regulatory activities associated with the registration and support of new and approved drug products. Seeks and incorporate regional and functional RA strategy into a global strate...

2 months ago seen See more...

Director, Regulatory Affairs Companion Diagnostics

Biospace

Basking Ridge, NJ

CDx development: Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for each country/region, both before and after CDx testing. At the time of implementation of a CDx study/...

2 months ago seen See more...

Associate Director, US Regulatory Affairs Strategy

Daiichi Sankyo, Inc.

Basking Ridge, NJ

Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for FDA meetings for assigned product. Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting minutes to capture the...

2 months ago seen See more...

Manager - Regulatory Affairs - Therapeutic Area

Biospace

Plainsboro, NJ

Compile and submit responses to FDA communications. MANAGER, THERAPEUTIC AREA: Compile, submit and maintain applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products. Create an...

4 weeks ago seen See more...

SENIOR MANAGER REGULATORY AFFAIRS

Tk-Chain Llc

Princeton, NJ

$80,000 - $170,000 a year

Ensures that appropriate CMC regulatory activities occur in support of both pre and post-approval submissions while meeting aggressive timelines and adhering to the highest quality standards. Must be able to effective articulate c...

2 months ago seen See more...

Clinical Trial Manager, Global Oncology Medical Affairs

Biospace

Basking Ridge, NJ

Support the preparation, set-up, and execution and reporting of all Global Oncology Medical Affairs operations Clinical Trial activities, ensuring adherence to timelines, budgets, project, and quality plans, and relevant ICH/GCP G...

a month ago seen See more...

Regulatory Affairs Consultant

Katalyst Healthcares And Life Sciences

Rahway, NJ

Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products' registration. Participate on product development te...

3 weeks ago seen See more...

Regulatory Affairs Consultant

Katalyst Healthcares & Life Sciences

Rahway, NJ

Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products\' registration. Participate on product development t...

3 weeks ago seen See more...

Senior Associate - Regulatory Affairs

Biospace

Princeton, NJ

Contribute to the preparation, review, approval, and dispatch of global submissions to regulatory applications (pre-submission activities, orphan drug applications, IND/INDs/CTAs/NDAs/MAAs etc.). Support the planning and conduct o...

a week ago seen See more...

Medical Affairs Operations Senior Manager-Americas (Hybrid)

Csl

Summit, NJ

Provide Medical Affairs (MA) project support regionally and engage team members to solicit project concerns and ideas for improvement. . Meet with MA Regional Head and Country Medical Leads to provide MA project status updates and...

3 weeks ago seen See more...

Summer 2024 - Regulatory Portfolio Management Internship

Bristol-Myers Squibb Company

Princeton, NJ

Co-lead GRST meetings in alignment with the GRS Culture Playbook to ensure high quality discussions & decisions; diligent follow-up with sub-team members to uphold accountabilities and drive decision making, project availability d...

2 weeks ago seen See more...

Associate Director - Regulatory Affairs - AD Promo

Biospace

Princeton, NJ

Provide strategic guidance for responsible products and disease states based on current regulatory environment and competitive landscape. Assess risk and advise on mitigation strategies to meet overall business need, while maintai...

3 weeks ago seen See more...

Associate Director, Medical Affairs - Program Management

Merck

Rahway, NJ

Support the SRO Lead in the execution of extensive, global initiatives, ensuring the program objectives and timelines are consistently met.. Facilitate the creation and approval of all project deliverables, including maintaining d...

a month ago seen See more...

Specialist - Regulatory Affairs

Biospace

Plainsboro, NJ

Therapeutic Area:. Assist Manager/Director in review of labeling for marketed products and new products as assigned. Maintain up-to-date knowledge of data requirements and formats, applicable current SOPs, regulations, and guideli...

4 weeks ago seen See more...

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...

4 weeks ago seen See more...

Associate Director / Director, Regulatory Affairs (Generic Medicines)

Cnam - Auditeurs - Accueil

Princeton, NJ

This role will work directly with the development and maintenance teams on the product registrations, through FDA communication and review process, amendments, supplements, and annual reports. Coordinates, reviews, and may prepare...

2 months ago seen See more...

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