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Regulatory Affairs Associate Director jobs in New Jersey

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ASSOCIATE DIRECTOR, REGULATORY AFFAIRS - INFLAMMATION & IMMUNOLOGY

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...

CompanyBiospace
AddressBasking Ridge, NJ
CategoryInformation Technology
Job typeFull time
Date Posted 2 weeks ago See detail

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...

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...

2 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...

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...

2 months 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 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...

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...

US Associate Director Payer & Access Strategy, Medical Affairs, Oncology (Remote)

Merck

Rahway, NJ

The US Associate Director Payer & Access Strategy Lead, Medical Affairs (US AD PASL) role supports the Global Medical and Scientific Affairs (GMSA) strategic priority "Invest in the growth, success and well-being of our people" an...

6 days ago seen See more...

Associate Manager, Regulatory Affairs (Hybrid)

Iff Family Of Companies

Hazlet, NJ

Working with a team of regulatory Specialists and Managers. This will require the ability to work in a team environment and contribute to collaborative projects. Providing support for all product compliance/regulatory, product cla...

7 days 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...

2 weeks ago seen See more...

Associate Director of Athletics for Internal Affairs

Kean University

Union, NJ

Please upload your resume/CV for automatic population of information to your Kean application. Your contact information, work experience and education will be automatically filled in. Please review all fields you will need to ve...

2 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...

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...

3 weeks ago seen See more...

Associate Director, Graduate Affairs Communications Specialist & CRM Administrator

Seton Hall University

Orange, NJ

The incumbent will assist with the general coordination of all graduate enrollment and recruitment efforts by providing critical strategic leadership where technology, data, reporting, and digital communications are concerned. M...

3 weeks ago seen See more...

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...

3 weeks ago seen See more...

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...

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...

3 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...

a month 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/...

a month ago seen See more...

Associate Director, CUSO Regulatory Interpretation and Accounting Advisory

Royal Bank Of Canada

Jersey City, NJ

Support the Consolidated U.S. Operation (CUSO) inclusive of RBC US Group Holdings, the U.S. Intermediate Holding Company (IHC) who is subject to the Dodd Frank Regulation YY requirements. It is subject to various regulatory filing...

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...

2 months 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...

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...

Sr. Director of Quality Assurance and Regulatory Affairs

Dynarex Corporation

Montvale, NJ

$160,000 - $185,000 a year

Stay abreast of regulatory requirements and changes, ensuring the organization's compliance with local, national, and international regulations. Develop and execute regulatory strategies to facilitate product approvals and certifi...

2 months ago seen See more...

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...

2 months ago seen See more...

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