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REGULATORY AFFAIRS SENIOR DIRECTOR - GLOBAL REGULATORY LEADER - OBESITY

To lead GRTs within Amgens GRAAS organization. To independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes...

CompanyBiospace
AddressWashington, DC
CategoryInformation Technology
Job typeFull time
Date Posted a month ago See detail

Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity

Biospace

Washington, DC

To lead GRTs within Amgens GRAAS organization. To independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes...

a month 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...

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Regulatory Affairs Specialist II

Bausch + Lomb

Remote

$65,000 - $95,000 a year

Responsible for general knowledge of pharmaceutical, consumer and medical device regulations in Regional and Local markets. Partners closely with cross-functional stakeholders to document registration strategy and implementation p...

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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...

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Lead for Global Regulatory Affairs

Biospace

King Of Prussia, PA

Degree in Biological Sciences or related health sciences. 12+ years experience in the pharmaceutical/health care industry, at least 8 years in Global Regulatory Affairs, Biologics Regulatory experience. 10+ years leadership experi...

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Director, Regulatory Affairs Advisor & Liaison

Capital One

Virginia, United States

Enjoy working with banking regulators Closely follow digital and technological developments in banking and financial services Understand and appreciate technology and cyber security risk management Relish interacting with senior l...

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State Government Affairs Manager

American Counseling Association

Alexandria, VA

$84K - $106K a year

Develop and implement the State Government and regulatory strategy for the counseling profession by utilizing the organizational work plan to meet needed goals and objectives. Research and analyze legislation, regulations, and pol...

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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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Senior Counsel. Global Regulatory Affairs

Visa

New York, NY

$201,500 - $262,000 a year

10+ years of relevant work experience with a Bachelors degree and J.D. Admitted to practice law in the United States and in good standing Strong academic credentials Excellent verbal and written communication skills Strong prefer...

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Quality and Regulatory Manager Nutraceuticals

Ashland, Llc

Kearny, NJ

Develops, implements, monitors, and continuously improves programs to ensure compliance with industry standards for food and dietary supplements (cGMP, 21 CFR 111, 117, HACCP, FSMA, SQF, etc.). Supports customer & other regulator...

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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)....

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Sr. Director, Regulatory Affairs Strategy

Taiho Oncology, Inc.

Pleasanton, CA

$240,000 - $283,000 a year

Responsible to represent the Regulatory Affairs position and decision in assigned Project Teams, due diligence assessments, and compliance remediations for Taiho Oncology, Inc., (TOI), projects including exploratory development an...

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Regulatory Affairs Specialist

Cybotic System

Ithaca, NY

Up to $80,000 a year

Remain current on all applicable regulatory guidances that impact the companys ability to legally market medical devices around the world and assist in updating relevant SOPs based on those changes. Remain current with all mandat...

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Senior Regulatory Affairs, Study Start Up Specialist

Cti Clinical Trial Services Inc

Covington, KY

$73K - $92.5K a year

Perform/ oversee compliance assessments against Food and Drug Administration (FDA) lists and documents any FDA activity discovered; notifies Study Manager of any FDA activity documented per CTI SOPs. Compile/ oversee site Regulato...

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Sr. Regulatory Affairs Specialist

Organ Recovery Systems, Inc.

Itasca, IL

From $90,000 a year

401(k). 401(k) matching. Dental insurance. Employee assistance program. Flexible schedule. Flexible spending account. Health insurance. Life insurance. Paid time off. Professional development assistance. Tuition reimbursement. Vis...

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Data Analyst - Regulatory Affairs

Adecco

Morris Plains, NJ

$ 32 - $ 34 / Hour

A Data Analyst - Regulatory Affairs position based out of Morris Plains, NJ is now available through Adecco Medical and Science. Responsibilities: Review formulas for Research and Development. Familiar with SAP Collaborate wit...

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Senior Regulatory Affairs Advisor

Cook Device Solutions

Remote

$100,000 - $125,000 a year

Authors submissions and other regulatory documents to obtain approval to bring new or modified products to market, including but not limited to FDA 510(k) submissions and EU MDR Technical Files. Manages communications with regulat...

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Government Affairs Manager

Stericycle

Illinois, United States

$91.8K - $116K a year

Lead development and implementation of a public affairs strategy including community relations, stakeholder engagement and grassroots constituent support for the Company. Identify, establish, and maintain relationships with local...

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Federal & State Government Affairs Manager

Cnh Industrial

Washington, DC

$132K - $167K a year

Develop relationships and serve as the liaison with Congress, the Administration, State & Local officials, coalitions and industry associations composed of companies with similar interests and viewpoints as on important matters; l...

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Director of Transmission Policy & Regulatory Affairs - East Coast

Equinor

Boston, MA

Lead Transmission Policy and regulatory efforts related to large-scale renewable and energy storage development across eastern region. Work in coordination with East CoastPolicy & Regulatory Lead to integrate actionable transmiss...

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Pipeline Regulatory Manager

Sinclair

Dallas, TX

Communicates regulatory, environmental and safety issues, best operating and maintenance practices, and continuous improvement efforts to all MidstreamRegional Operating areas focusing on the operation of HEPs pipelines and asso...

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VP of Quality and Regulatory Affairs

Oxenham Group Llc

Woburn, MA

Develop and implement plans to ensure product product and market approval in various regions. Prepare and submit all regulatory filings. Responsible for regulatory compliance ensuring local and international regulations and standa...

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Mgr Regulatory Affairs

Elevance Health

San Juan, PR

Oversees preparation and submission of regulatory filings, including license applications and renewals, data reports, and material change notifications. Supports market conduct exam activities. May interact with state regulators w...

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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...

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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...

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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....

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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...

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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...

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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...

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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...

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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, Gan & Lee Pharmaceuticals, Glaukos, Innovative Skincare, Katalyst Healthcares & Life Sciences, Kindeva Drug Delivery,

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