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Regulatory Affair Associate jobs

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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 2 weeks 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...

2 weeks ago seen See more...

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...

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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...

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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...

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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...

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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...

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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...

4 days ago seen See more...

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...

4 weeks ago seen See more...

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)....

4 weeks ago seen See more...

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...

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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...

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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...

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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...

2 months ago seen See more...

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...

2 months ago seen See more...

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...

2 months ago seen See more...

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...

6 days ago seen See more...

Associate Director of Multicultural & International Student Affairs New

Simpson College

Indianola, IA

Developing, planning and implementing campus-wide diversity related resources, services and programs for multicultural, international and marginalized students to ensure student success and belonging. Developing, planning and impl...

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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,...

2 weeks ago seen See more...

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...

3 weeks ago seen See more...

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...

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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...

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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...

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Regulatory Affairs Manager - Now Hiring

Abbott Laboratories

Texas, United States

$95000 - $190000 per year

Develops sound global regulatory strategies for new and modified medical devices. Prepares robust regulatory applications to achieve departmental and organizational objectives. Creates, reviews and approves engineering changes. Pr...

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Associate Director, Field Medical Affairs- Hematology (Chicago area)

Biospace

Chicago, IL

Want to be a part of a pre-launch stage Field Medical team a with potential for multiple launches.. Highly skilled in the art of strategic conversation along with a demonstrated ability to assess issues, as they arise and adapt ap...

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Associate Director, US Medical Advertising and Promotions Regulatory (GI)

Biospace

Lexington, MA

Mentor and develop staff. Supervise, trains and provides technical and regulatory guidance to staff. You will serve as the chair of promotional review meetings, and assist commercial with the planning and prioritization of propose...

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Sr. Associate Provost & Sr. Assoc. VP Academic Affairs

Texas Southern University

Houston, TX

Represents the Provost and Sr. Vice President for Academic Affairs as needed. Work collaboratively with the Directors of the Office of Institutional Research, the Office of Research and Sponsored Programs, the Office of Enrollment...

2 days ago seen See more...

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...

4 weeks ago seen See more...

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...

4 weeks ago seen See more...

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...

4 weeks ago seen See more...

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...

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What are the top cities open Regulatory Affair Associate jobs?

There are open Regulatory Affair Associate jobs in several cities including Cincinnati, Plainsboro, Boston, Parsippany, Hoschton, Princeton, Seattle, Piscataway, Totowa, Englewood Cliffs, Skaneateles, Des Moines, Gibbstown, Bloomingdale, Stamford,

What companies are hiring for Regulatory Affair Associate jobs?

The top companies hiring now for Regulatory Affair Associate jobs are Actalent, Baylor College of Medicine, Capleo Global, ClinChoice Inc, Danaher, Epitope Diagnostics, Inc., Katalyst Healthcares & Life Sciences, Meitheal Pharmaceuticals Inc, Pyramid Consulting, Inc., Pyramid Consulting, Inc., Teva Pharmaceuticals, Therapeutics Inc., Zobility,

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