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REGULATORY AFFAIRS ASSOCIATE - DRUG PRODUCTS (PRINCETON, NJ (USA), US)

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...

CompanyLaboratoire Guerbet
AddressPrinceton, NJ
CategoryInformation Technology
Job typeFull-Time
Date Posted 3 days ago See detail

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...

Regulatory Affairs Associate Manager

Comtec

Remote

$35 - $43 an hour

Validate product composition, ingredient lists, develop nutritionals and advise on/approve regulated claims for compliance under US laws and regulations. Participate in validation of marketing campaigns and review of associated ma...

Jr Regulatory Affairs Associate

Codetru

Lake Forest, IL

$22 - $26 an hour

401(k). Dental insurance. Health insurance. Paid time off. Vision insurance. 8 hour shift. Medical device or Pharma: 1 year (Required). Lake Forest, IL 60045: Relocate before starting work (Required)....

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,...

Remote - Sr. Regulatory Affairs Associate - Pharmaceuticals

Fresenius Medical Care

Waltham, MA

Provides regulatory assessment and support. Evaluates and assesses regulatory impact of proposed product changes. Contributes to strategic planning as regulatory representative on interdepartmental pharmaceuticals development team...

Remote - Regulatory Affairs Associate II Pharma

Fresenius Medical Care

Waltham, MA

$87.1K - $110K a year

Provides regulatory assessment and support. Evaluates and assesses regulatory impact of proposed product changes. Contributes to strategic planning as regulatory representative on interdepartmental pharmaceuticals development team...

Regulatory Affairs Associate (On-Site / Remote)

Imbed Biosciences, Inc

Remote

$67.4K - $85.4K a year

Research and interpret regulations related to the development, manufacturing, and marketing of products in the Medical Device industry. Review product labeling, packaging, and promotional materials to ensure compliance with regula...

Sr. Regulatory Affairs Associate

Actalent

Thousand Oaks, CA

Independently plan, prepare, coordinate, track, follow-up, and obtain clearances for medical device submissions including US 510(k), Health Canada licenses, AU technical files, Japan, MEA and other countries as well as for human t...

Regulatory Affairs Associate

American Cybersystems

Newark, CA

The successful candidate will play a crucial role in ensuring compliance with regulatory standards and guidelines related to product labeling. This position offers an exciting opportunity to contribute to the development and comme...

Regulatory Affairs Associate

Obagi Cosmeceutical Llc

Long Beach, CA

Reviewing ingredients for regulatory compliance for different markets and product categories. Provide comprehensive regulatory assessments for ingredients, new products, and reformulations using appropriate databases. Partner with...

Principal, International Regulatory Affairs (Associate Vice President)

Bath & Body Works

New Albany, OH

Accountable for establishing high-level regional compliance critical action plans and general timelines. Accountable for establishing regulatory compliance strategy and execution recommendations for international market entry. Pro...

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...

Head/ Sr Director of Global Regulatory Affairs New

Predicine, Inc

Hayward, CA

Responsible for setting strategy and leading the Predicine Global Regulatory Affairs organization. Organize and oversee the preparation, review, and submission of regulatory documents to regulatory authorities for In vitro diagnos...

Director Regulatory Affairs New

Nikang Therapeutics Inc

Wilmington, DE

Integrate knowledge of global regulations to provide regulatory advice to multidisciplinary teams to support clinical and nonclinical development, including preparation and maintenance of IND and CTA filings. Lead multidisciplinar...

Manager - Regulatory Affairs - Therapeutic Area New

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...

Associate Director, Regulatory Affairs - West Chester, PA

Teva Pharmaceuticals

United States

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...

Vice President Regulatory Affairs, Obesity

Biospace

Thousand Oaks, CA

Develops the vision of the Regulatory Therapeutic Area for Obesity and Obesity Related Conditions (ORCs) and drives its execution, ensuring the globalization of strategy and process. Represents the Regulatory Affairs Therapeutic A...

Senior Associate Regulatory Affairs

Amgen

Washington, DC

Execute the international regulatory strategy and regulatory plans.. Prepare supportive documentation for regulatory deliverables.. Support regulatory product compliance (e.g. RIM, PMCs, ESC levels, and agency commitments).. Suppo...

Regulatory Affairs Specialist I

Fresenius Kabi Ag

Lake Zurich, IL

Collaborate with local and international colleagues to generate high quality submissions to obtain drug and/or medical device approvals in target markets. Gather design and development information on products from cross-functional...

Regulatory Affairs Specialist

Argen Corporation

San Diego, CA

Argen is a global leader in dental manufacturing with headquarters in San Diego, CA, subsidiaries in Canada, Germany, UK, and China, and sales in 105 countries worldwide. Our Awesome Benefits!Working for a growing innovative compa...

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...

Senior Associate Regulatory Affairs

Biospace

Washington, DC

Execute the international regulatory strategy and regulatory plans. Prepare supportive documentation for regulatory deliverables. Support regulatory product compliance (e.g. RIM, PMCs, ESC levels, and agency commitments). Support...

Associate Director, Regulatory Affairs

American Cybersystems

San Rafael, CA

One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022). ClearlyRated Client Diamond Award Winner (2020). One of the Largest Certified MBE Companies in the NMSDC Network...

Associate Manager of North America Regulatory Affairs

International Flavors & Fragrances

Palo Alto, CA

$105.60 - $118.80 an hour

Responsible for overall management of the Animal Nutrition product portfolio. Draft submissions such as US feed GRAS, US AAFCO submissions, and Canadian feed approvals. Serve as the main point of contact for the Animal Nutrition b...

Associate Director, Graduate Affairs Communications Specialist & CRM Administrator New

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...

Associate Vice President, International Government Affairs New

Biospace

Washington, United States

Be the accountable single point of contact for International Government Affairs and direct liaison for the Executive VP of Lilly International Business Unit. Lead the International vision and strategy, planning and achieving of hi...

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...

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...