Regulatory Affairs Associate Director jobs in Bridgewater, NJ

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ASSOCIATE DIRECTOR, REGULATORY AFFAIRS

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...

CompanyBausch + Lomb
AddressBridgewater, NJ
CategoryInformation Technology
Job typeOther
Date Posted a month ago See detail

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...

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....

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...

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...

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...

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...

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/...

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...

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...

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...

Associate Director, Regulatory Affairs - Labeling: Job ID - 1297NJ

Ascendis Pharma

Princeton, NJ

Medical insurance. Vision insurance. Dental insurance. 401(k). Paid maternity leave. Paid paternity leave. Commuter benefits. Disability insurance....

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...

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...

Regulatory Project Manager (RPM), Associate Director

Merck Sharp & Dohme

Rahway, NJ

$122,800 - $193,300 a year

Demonstrates strong project management skills in handling projects of significant complexity within the end-to-end regulatory drug development process. Proactively identifies areas that need Regulatory Project management support a...

Senior Administrative Associate - Regulatory Affairs

Merck Sharp & Dohme

Rahway, NJ

$78,700 - $123,800 a year

General secretarial/clerical tasks including scheduling of complex meetings, management of calendar, filing of monthly expense reports for multiple therapeutic area regulatory liaisons General support of the Rahwaybased staff, as...

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...