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REGULATORY AFFAIRS ASSOCIATE III

Who we areTogether, were on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. Write, review and compile documentation and data necessary for submission of assig...

CompanyTeva Pharmaceuticals
AddressLorida, FL
CategoryInformation Technology
Date Posted 4 weeks ago See detail

Regulatory Affairs Associate III

Teva Pharmaceuticals

Lorida, FL

Who we areTogether, were on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. Write, review and compile documentation and data necessary for submission of assig...

Associate Director, Regulatory Affairs (Advertising and Promotion)

Bausch Health

Bridgewater, NJ

Provides regulatory review of Advertising and Promotional materials, new campaigns and launch strategies for assigned products. Assures timely and accurate review of Advertising and Promotional material to meet internal timelines...

Regulatory Affairs Associate - North Chicago, United States - Validation Associates

Validation Associates

United States

As the professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration in EURI/MENAP global. Individual shall develop partnership...

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...

Manager Regulatory Affairs New

Teva Pharmaceuticals

Parsippany, NJ

Requires a Bachelors degree in Pharmacy Administration, Pharmaceutical Science, Regulatory Affairs, or a related field, and 3 years of Regulatory Affairs experience. Must have 2 years of sterile/ parenteral dosage form experience...

Associate Director, Regulatory Affairs Innovation

Biospace

Irvine, CA

Leads and/or supports medical device / pharma development, including Clinical Outcome Assessment tools and Digital Health Technologies, and global filing activities from a regulatory standpoint from initial product concept through...

Senior Manager/Associate Director, Regulatory Affairs, Strategic Global Labeling - Combination

Biospace

North Chicago, IL

Develop and direct strategic regulatory planning, creation, and revision of labeling for combination product and device submissions (pre and post approval) with an understanding of Global requirements to lead the Labeling Sub team...

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...

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...

Associate Director, Regulatory Affairs - Remote OR West Chester, PA

Teva Pharmaceuticals

West Chester, PA

Spearhead the delivery of successful investigational and regulatory license applications and product life cycle management submissions with the Global Regulatory Affairs Team from initial filing through post-approval management. P...

Associate Director, Regulatory Affairs - Inflammation & Immunology

Biospace

New York, NY

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...

Associate Director, Regulatory Affairs - Inflammation & Immunology

Biospace

New York, NY

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...

Associate Director, Regulatory Affairs Advertising and Promotion

Biospace

California, United States

Provides commercial regulatory support to high-volume brands or therapeutic area and projects without managerial oversight, as appropriate. Reviews and approves promotional materials.. Serves as PRC Chair for one or more high-volu...

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...

Associate Director, Regulatory Affairs Strategy - Genetic Medicine

Biospace

New York, NY

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...

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...

Senior Manager/Associate Director of Regulatory Affairs

Tempus

Chicago, IL

Developing and leading global regulatory strategies to support business objectives. Leading submissions and correspondence with global regulatory authorities, including 510(k),PMA, De Novo authorizations, IDE, MDR CE marking, UKCA...

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,...

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...

Corporate Affairs Associate Director- Oncology

Biospace

Washington, DC

Responsible for developing communication plans and materials that will drive awareness of data milestones, approvals, data publications and launches for priority assets in close partnership with the relevant Global/Regional Corpor...

Senior Regulatory Affairs Specialist

Johnson & Johnson

Danvers, MA

...

Regulatory Affairs Manager

Amgen

Washington, DC

Provide Guidance and Leadership on mechanisms to optimize product development and regulatory approvals.. Develops the international regulatory strategy and contributes to global regulatory plans.. Support regulatory product compli...

Senior Manager CMC Regulatory Affairs

Biospace

Basking Ridge, NJ

Responsible for CMC/CP product development activities to lead the regulatory standpoint during early phase, development, submissions and post market requirements. Participate in IOPS cross-functional meetings for program-specific...

Director or Senior Director, Regulatory Affairs

Veranex, Inc.

San Jose, CA

$165,000 - $263,000 a year

Responsible for managing and prioritizing workload for regulatory staff. Develops and establish strategic regulatory plans and interfaces with project team members, both within the organization and with a diverse range of clients,...

Regulatory Affairs Specialist III

Boston Scientific

Maple Grove, MN

Under direct supervision of the RA Project Manager, or Department Manager, assists in preparing moderately complex submissions to gain approvals for clinical research, export, and commercial distribution, such as: IDE, IDES, IDE...

Senior Product Stewardship & Regulatory Affairs Specialist Job

Arkema

United, PA

Prepare and maintain commercial and R&D composition databases, SDSs and labels, packaging requirements, certificates of compliance (Kosher, FDA, RoHS etc.), product registrations and approvals (including FIFRA, NSF, UL, etc.), for...

Investment Funds, Regulatory Associate

An American Law Firm

Washington, DC

Requires one to five years of experience working as an Associate in the Investment Management practice group of a global law firm. Experience researching and preparing memoranda regarding the regulation and operation of private in...

Manager, Global Regulatory Affairs, Marketed Products - Now Hiring

Takeda Pharmaceutical

Bronx, NY

$186,000 per year

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas and. I further attest that...

VP/TA Head, General Medicine - Global Regulatory Affairs

Merck

Rahway, NJ

Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.. Contributing to the continuous improvement of the operating model for regulatory a...

Regulatory Affairs Intern (Onsite)-Summer-Fall 2024

Becton Dickinson

Covington, GA

Assist with product submissions and regulatory assessments. Ensure compliance with all relevant regulatory requirements. Improve departmental procedures and processes. Assist with regulatory assessments for design change and non-d...