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Specialist - Regulatory Affairs
3 weeks ago
Novo Nordisk Plainsboro, United States**About the Department*** · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA ...
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Specialist - Regulatory Operations - Submissions
2 weeks ago
Novo Nordisk Princeton, United States**About the Department*** · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA ...
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Regulatory Affairs Specialist Ii
3 weeks ago
Katalyst Healthcares & Life Sciences Inc Edison, United States**Responsibilities**: · - This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of pr ...
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Specialist - Regulatory Affairs
2 weeks ago
Novo Nordisk A/S Plainsboro, United StatesProvide proactive support and technical assistance to more experienced regulatory personnel. Identify issues and inform appropriate individuals. Ability to work with less supervision than Associate. Take initiative to assist with overflow in other ar Regulatory Affairs, Regulator ...
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Specialist - Regulatory Affairs
1 week ago
Novo Nordisk Plainsboro, United StatesAbout the DepartmentThe Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to prov ...
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Specialist - Regulatory Affairs
2 weeks ago
Novo Nordisk Plainsboro, United States Full timeAbout the Department · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to ...
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Specialist - Regulatory Affairs
1 week ago
Novo Nordisk Plainsboro, United StatesAbout the Department · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to ...
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Regulatory Specialist
2 days ago
Hackensack Meridian Health Trenton, United StatesHackensack Meridian Health Regulatory Specialist Hackenack , New Jersey Apply Now Our team members are the heart of what makes us better.At Hackensack Meridian Health we help our patients live better, healthier lives and we help one another to succeed. With a culture rooted in co ...
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Regulatory Specialist
2 days ago
Net2Source Inc. Rahway, United StatesJob Description: · Position: Regulatory Operations Specialists - II (Associate) · Location: DeSoto, KS 66018 · Duration: 15+ Months (Extendable) · Pay Rate: $26.75/hr on W2. · Must have: · • Recent grad(BS/MS) - DO NO PHD with scientific background- are Ok to submit as long as t ...
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Regulatory Specialist
2 weeks ago
Colgateinvestors Piscataway, United StatesSite upgrade in progress. You will not be able to apply at this time. Please be patient and check back with us later. · Established in 1806 as a small soap and candle business in New York City, Colgate-Palmolive is now a truly global company with products sold in over 200 countr ...
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Regulatory Specialist
2 weeks ago
eTeam Rahway, United StatesRegulatory Operations Specialists - II (Associate) · Rahway, NJ- Hybrid schedule (require to be onsite for 3 days/week -Tuesday and Wednesday fixed) 3rd day is optional. · 12 Months contract · Pay Rate: $26.56/hr on w2 · Increase your chances of reaching the interview stage b ...
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Regulatory Specialist
1 week ago
iConsultera Rahway, United StatesTitle: Labeling Specialist · • Under general supervision, responsible for the preparation of high-quality labeling documents for submission to the US Food and Drug Administration (FDA). · • Ensure that product labeling is updated in accordance with FDA regulations and corporate ...
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Regulatory Specialist
2 weeks ago
iConsultera Rahway, United StatesTitle: Labeling Specialist · Under general supervision, responsible for the preparation of high-quality labeling documents for submission to the US Food and Drug Administration (FDA). · Ensure that product labeling is updated in accordance with FDA regulations and corporate gu ...
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Regulatory Specialist
2 weeks ago
iConsultera Rahway, United StatesTitle: Labeling Specialist · • Under general supervision, responsible for the preparation of high-quality labeling documents for submission to the US Food and Drug Administration (FDA). · • Ensure that product labeling is updated in accordance with FDA regulations and corporate ...
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Specialist, Regulatory
4 days ago
Stefanini South Plainfield, NJ, United StatesExciting opportunity awaits, let us help you get started · This position will support various Project Managers in the review technical documents such as Remedial Investigation Reports and Remedial Action Work Plans, oversight of soil and groundwater investigation/sampling activit ...
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Regulatory Affairs Specialist
2 weeks ago
Brenntag Iselin, United StatesStage Picture:brenntag_other_8.jpgJobTitle:Regulatory Affairs Specialist - PharmaLocation:South Plainfield/USAEmployment Type:EmployeeRegulatory Affairs Specialist - PharmaOur team in South Plainfield currently has an opening for a Regulatory Affairs Specialist - PharmaYOUR ROLE ...
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Regulatory Affairs Specialist
1 week ago
Brenntag Iselin, United StatesStage Picture: · JobTitle: · Regulatory Affairs Specialist - Pharma · Location: · South Plainfield/USA · Employment Type: · Employee · Regulatory Affairs Specialist - Pharma · Our team in · South Plainfield · currently has an opening for a · Regulatory Affairs Speciali ...
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Freelance Senior Regulatory Specialist
2 weeks ago
MRM Princeton, United StatesJob Title: Senior Regulatory Operations Specialist · About this role: · The Senior Regulatory Operations Specialist position is an integral part of MRM for Health and the Regulatory Operations capability. Regulatory Operations is accountable and responsible for the preparation, r ...
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Specialist - Regulatory Operations - Submissions
2 weeks ago
Novo Nordisk A/S Princeton, United StatesThe Specialist, Regulatory Operations - Submissions supports the development of submission plans created for regulatory submissions. This individual will be responsible for supporting the preparation, delivery, archiving and tracking of Promotional r Operations, Regulatory, Speci ...
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Regulatory Operations Specialists
2 weeks ago
Intelliswift Software Inc Rahway, United StatesRegulatory Operations Specialists - II (Associate) · Job ID: · Qualifications: · Education Requirements: · • Bachelor's degree in a relevant discipline such as animal science, veterinary technology, immunology, toxicology/pharmacology, chemistry, biology, business, regulatory ...
Regulatory Specialist - Hightstown, United States - Novitium Pharma
2 weeks ago
Description
Regulatory Specialist (East Windsor, NJ) (Multiple Openings).Review, manage and write regulatory submissions electronically which include New ANDA filings, Complete Response letters, Information requests, Amendments to the ANDA's (Labeling, Chemistry & Bioequivalence) of different dosage forms (Tablet, Capsule, Liquid & Solutions); responsible for filing the Post Approval Supplements like CBE-0, CBE-30 (Changes being effective in 30 days) and Prior Approval Supplements (PAS); submitting dossiers electronically after the approval of initial product submissions (ANDA); review of the leachable and extractable reports generated for the oral Liquid & Solution drug products.
Must have bachelors in Pharmaceutical sciences / biology / microbiology / chemistry / chemical / Regulatory Affairs / Related + 1 year exp.
as Regulatory Specialist /Quality Control Analyst / Chemist / Analyst / Scientist/ Research Associate / Related. Respond to HR Manager, Job ID # RS-24, Novitium Pharma LLC, 70 Lake Drive, East Windsor, NJrecblid 37ha71bt1y0gjulbuhqkvk0fq7o40b