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ASSOCIATE DIRECTOR / DIRECTOR, REGULATORY AFFAIRS (GENERIC MEDICINES)

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...

CompanyCnam - Auditeurs - Accueil
AddressPrinceton, NJ
CategorySales/marketing
Job typeFull-Time
Date Posted 2 months ago See detail

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...

Attorney Government and Regulatory Affairs

Malamut & Associates

Cherry Hill, NJ

401(k). Competitive salary. Health insurance. Paid time off. At least 1-3 years experience in direct handling of public sector clients. Juris Doctor Degree. Admission to New Jersey Bar. Currently in Good Standing with the New Jers...

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...

Regulatory Affairs Consultant

Katalyst Healthcares & Life Sciences

Morristown, NJ

$113K - $143K a year

Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices. We have a few immediate job opportunities available in D...

2 months ago seen See more...

Director, Science & Regulatory Affairs

Biotechnology Innovation Organization

Washington, DC

Excellent communications skills, including writing and speaking skills Background in biology, drug development, and the life sciences Excellent research skills, including problem-solving ability and attentiveness to detail Ability...

2 months ago seen See more...

Director of Regulatory Affairs

University Of Advancing Technology

Tempe, AZ

Routinely review documents and conduct quality checks while verifying compliance and regulatory mandates are met. Develop and execute regulatory strategies to support product development, registration, and commercialization plans....

2 months ago seen See more...

Director, Regulatory Affairs

Biospace

Waltham, MA

Interact with other departments to develop regulatory strategy and submission plans for quality and timely filings. As a member of program teams, provide global regulatory guidance regarding requirements for clinical development a...

2 months ago seen See more...

Senior Advisor/Director, Global Regulatory Affairs – CMC

Biospace

Indianapolis, IN

Deep technical knowledge of synthetic molecule CMC drug development science(s). Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations. Development...

2 months 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...

2 months ago seen See more...

Director of Regulatory Affairs

University Of Advancing Technology

Tempe, AZ

Routinely review documents and conduct quality checks while verifying compliance and regulatory mandates are met. Develop and execute regulatory strategies to support product development, registration, and commercialization plans....

2 months ago seen See more...

Assistant Business Affairs Manager

Cast & Crew

Burbank, CA

Manage clients' talent-related business matters including, but not limited to, talent estimating, contracting talent, and processing payments. Comprehensive knowledge in state labor requirements as well as SAG/AFTRA/AFM commercial...

2 months ago seen See more...

VP Government and Regulatory Affairs

Uchealth

Aurora, CO

$227,510 - $341,266 a year

Collaborates with executive leadership to determine organizational priorities and goals;. Researches and monitors industrial, professional and national developments;. Integrates data from multiple sources to support decision makin...

2 months ago seen See more...

Director, International Regulatory Affairs Advertising & Promotion (Remote Eligible)

Abbvie

Illinois, United States

$159K - $201K a year

Reviews and evaluates the global industry environment (e.g., regulatory, legal, and political climate), and plans strategically for overall system of regulatory communications. Provides functional input on key initiatives impactin...

2 months ago seen See more...

Vice President, Government & Regulatory Affairs

Engie

Washington, WA

A bachelors degree in public administration, political science, economics, business administration, or related field A minimum of fifteen (15) years in the role of advocacy and legislative policy, leadership level engagement in i...

2 months ago seen See more...

Medical Affairs Manager – Pharmaceuticals

Baxter

Deerfield, IL

$120,000 - $165,000 a year

Executing on the defined Medical Affairs strategy Collaborating with marketing and sales teams to support product launches and therapy campaigns Serving as a subject matter expert and providing training internally and externally w...

2 months ago seen See more...

Vice President Regulatory Affairs, Obesity

Amgen

Thousand Oaks, CA

$387,860 - $450,000 a year

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...

2 months ago seen See more...

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...

2 months ago seen See more...

Healthcare Facilities Regulatory Manager

Cref

Fort Lauderdale, FL

$120K - $152K a year

The Healthcare Facilities Regulatory Manager supports an internal and external team of facility, environmental and safety professionals while working collaboratively with various teams throughout the organization to review current...

2 months ago seen See more...

Federal Government Affairs Manager (hybrid)

Nisource

Washington, DC

$125,800 - $188,600 a year

Collaborates with the Director of Federal Government Affairs to drive the development and execution of Government Affairs strategies designed to meet the organization's strategic goals and objectives. Builds and maintains relation...

2 months ago seen See more...

Vice President, Government & Regulatory Affairs

Engie

Washington, DC

$184,200 - $275,310 a year

A bachelors degree in public administration, political science, economics, business administration, or related field. A minimum of fifteen (15) years in the role of advocacy and legislative policy, leadership level engagement in...

2 months ago seen See more...

Executive Director, Advertising & Promotions Regulatory Affairs

Ortho Dermatologics

Palm Beach, FL

$280,000 - $320,000 a year

Manages the Regulatory Promotional reviews for prescription drugs who represent Regulatory Affairs on the promotional review committee for marketed products. This position may require reviewing promotional materials if the company...

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...

Government Affairs Manager/Legislative Assistant

Kutak Rock Llp

Washington, DC

$45,000 - $53,000 a year

Manage and plan the ECAs association meetings Develop communication documents for local communities to understand issues related to DOE activities and nuclear energy Track and analyze policy related to environmental cleanup, nucl...

2 months ago seen See more...

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...

2 months ago seen See more...

Director, Regulatory Affairs

Nyserda

New York, NY

$147,758 - $185,851 a year

Attract the private sector capital investment needed to expand New Yorks clean energy economy. Overcome barriers to using clean energy at a large-scale in New York. Enable New Yorks communities and residents to benefit equitably...

2 months ago seen See more...

Deputy General Counsel for the Regulatory Affairs Division

Nyc Careers

New York, NY

$155,970 - $165,970 a year

Agency: HOUSING PRESERVATION & DVLPMNT Job type: Full-time Title Classification: No exam required We maintain building and resident safety and health. We create opportunities for New Yorkers through housing affordability. We engag...

2 months ago seen See more...

Head of Regulatory Affairs Policy & Regulatory Intelligence

Amgen

Thousand Oaks, CA

$153K - $193K a year

Lead teams of policy experts and subject matter experts to accomplish policy goals. Recruit and retain highly qualified and diverse professional policy and Regulatory Intelligence professionals, ensuring they are appropriately qua...

2 months ago seen See more...

Vice President, Student Affairs and Enrollment Management

Alcorn State University

Lorman, MS

Knowledge and understanding of post-secondary education. Clear and articulated understanding of equity and how to use data to identify strategies to close enrollment and achievement gaps. Competency to conduct long and short-range...

4 weeks ago seen See more...

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What companies are hiring for Regulatory Affair Manager jobs?

The top companies hiring now for Regulatory Affair Manager jobs are Abbott Laboratories, Ametek, Inc., AMETEK, Inc., Amgen, Bel Brands USA, Congruent, Cordance, CVS Health, Daikin Comfort Technologies, Evergy, Tekskills, Therapeutics Inc., Truvian Sciences, Yamaha Motor,

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