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Regulatory Affair Director jobs in Skillman, NJ

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ASSOCIATE DIRECTOR - REGULATORY AFFAIRS - AD PROMO

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...

CompanyBiospace
AddressPrinceton, NJ
CategoryRetail
Job typeFull time
Date Posted 2 weeks ago See detail

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...

2 weeks ago seen See more...

Senior Associate - Regulatory Affairs New

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...

9 hours ago seen See more...

Director, Regulatory Labeling New

Biospace

Bridgewater, NJ

CCDS. regional prescribing information (e.g., USPI, SmPC, Japan PI). medication guides. patient information/leaflet/instructions for use. package labels. coordinating with multidiscipline team for US commercial implementation...

9 hours 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...

a month 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....

a month ago seen See more...

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 days 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...

a month 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...

a month 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...

a month ago seen See more...

Medical Director, Bladder - Global Medical Affairs Oncology

Johnson & Johnson

Raritan, NJ

This position requires a minimum of an advanced degree in medicine (i.e. M.D. or equivalent). A trained Oncologist, or an individual with substantial previous experience in conducting oncology clinical studies is highly desired....

2 weeks 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...

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 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...

3 weeks ago seen See more...

Medical Affairs-Scientific Director CV Renal

Biospace

Plainsboro, NJ

Identify and anticipate potential trends, changes to market conditions and areas of opportunity aligned with Therapeutic Area priorities. Utilizes subject matter expertise and analytical tools to provide deeper customer knowledge...

2 weeks ago seen See more...

Senior Director, Global Medical Affairs Strategy - Solid Tumors

Genmab A/S

Princeton, NJ

Develop and execute the overall Medical Affairs Strategy for designated product in NSCLC therapeutic area. Serve on Compound Development Team as Global Medical Affairs representative; Co-Lead Global Commercialization Team. Serve a...

2 weeks ago seen See more...

Manager Global CMC Regulatory Affairs

Johnson & Johnson

Titusville, NJ

Develops and realize global regulatory strategies for development compounds and marketed products according to scientific and risk-based principles. Participates as regulatory lead on CMC/VCM teams and represents CMC RA by provid...

3 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...

a month ago seen See more...

Associate Director Regulatory Labeling

Acadia Pharmaceuticals Inc.

Princeton, NJ

Support with developing draft labeling text (e.g. USPI, PPI, Med Guide, EU SmPC, EUPIL) to support marketing applications and labeling update of approved package inserts to support product lifecycle management. Support implementat...

a month ago seen See more...

Associate Director Regulatory Process Development

Johnson & Johnson

Wycombe, PA

Support the global Regulatory Process strategy that aligns with overall business objectives. Support the generation and implementation of an E2E process management model across Global Regulatory Affairs (GRA), including connectiv...

2 weeks ago seen See more...

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