Regulatory Specialist
2 weeks ago
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, NJ 08520.
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Specialist, Regulatory Affairs
5 days ago
East Winsdor, United States Shiseido Full timeJob Summary: The Specialist in Regulatory Affairs will be assigned to the Risk Analysis and Strategy group. Responsible for ensuring regulatory compliance of raw materials, formulas and will handle projects or other responsibilities aligned to make saleable products globally. Primary Duties & Responsibilities: Gathering, generating, and managing technical...
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Specialist, Regulatory Affairs
4 days ago
East Winsdor, United States Shiseido Full timeJob Summary: The Specialist in Regulatory Affairs will be assigned to the Risk Analysis and Strategy group. Responsible for ensuring regulatory compliance of raw materials, formulas and will handle projects or other responsibilities aligned to make saleable products globally. Primary Duties &...
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Regulatory Affairs Manager
1 month ago
East Brunswick, United States International Staff Consulting Full timeThe Regulatory Affairs Manager will create, evaluate and execute domestic and/or international regulatory tasks related to the following: global submissions, technical file compilation, facility registrations, special projects and strategy to drive market growth worldwide. Additionally, this individual will provide leadership and guidance to the Regulatory...
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Associate Director Regulatory Writing
2 weeks ago
East Hanover, United States Novartis Full time**About the Role**: This is a remote position Major Activities 1. To author, review and/or independently handle high quality clinical and safety documents: Clinical Study Reports (CSR), Risk Management Plans (RMP), CTD submission documents (clinical overviews, summaries of clinical efficacy and safety, summaries of clinical pharmacology and...
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Specialist, Environment, Health, Safety
2 weeks ago
East Windsor, United States Shiseido Full timeWe are seeking a dedicated Environmental, Health, and Safety (EHS) Specialist to join our manufacturing team. The role entails implementing and overseeing safety protocols, regulatory compliance, and sustainability initiatives within our manufacturing facility. The ideal candidate will possess a strong understanding of cGMP manufacturing processes, relevant...
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Compliance Specialist
5 days ago
Windsor, United States Michael Page Full timeAs a Quality Compliance Specialist, you will play a vital role in maintaining and enhancing our commitment to quality and compliance within our manufacturing processes. You will collaborate closely with cross-functional teams to ensure adherence to regulatory requirements and internal quality standards, ultimately contributing to the delivery of superior...
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FDA Compliance Specialist
2 weeks ago
Windsor Locks, United States A.R. Mazzotta Full timeA. R. Mazzotta has a new contract opening at a local distribution facility located in Hartford County. We are looking for a person who has knowledge of the regulations and guidelines set forth by the U.S. Food and Drug Administration (FDA). This pers Compliance Specialist, Compliance, Specialist, Healthcare, Staffing, Regulatory
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Compliance Specialist
8 hours ago
Windsor, United States Swiss Re Full timeSwiss Re's Regulatory Operations team has a wonderful opportunity for a diligent, detail-minded Compliance Specialist to support our North America product offerings and policy issuance! About the role This role provides direction and support to the business units throughout the development, preparation and implementation of the product filings life...
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EH&S Specialist
4 weeks ago
Windsor, United States MATIV HOLDINGS INC Full timeDescription Description: Our EH&S Specialist supports Mativ's Sustainable & Adhesive Solutions Function. The EH&S Coordinator will provide environmental health and safety support to assigned operations and will ensure that all practices are in compliance with federal, state, and local laws, regulatory and ISO requirements. The position will be responsible...
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EH&S Specialist
4 weeks ago
Windsor, United States Schweitzer-Mauduit International, Inc. Full timeDescription: Our EH&S Specialist supports Mativ's Sustainable & Adhesive Solutions Function. The EH&S Coordinator will provide environmental health and safety support to assigned operations and will ensure that all practices are in compliance with federal, state, and local laws, regulatory and ISO requirements. The position will be responsible for...
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Environmental Compliance Specialist
3 weeks ago
East Hartford, United States Raytheon Technologies Corporation Full timePratt & Whitney is looking for a motivated individual who can effectively manage a diverse range of environmental regulatory compliance program requirements across multiple industrial manufacturing sites. The candidate would oversee programs as a lea Compliance Specialist, Environmental, Compliance, Specialist, Manufacturing, Healthcare
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EH&S Specialist
2 weeks ago
Windsor, United States (SWM) Schweitzer-Mauduit International, Inc. Full timeDescription: Our EH&S Specialist supports Mativ’s Sustainable & Adhesive Solutions Function. The EH&S Coordinator will provide environmental health and safety support to assigned operations and will ensure that all practices are in compliance with federal, state, and local laws, regulatory and ISO requirements. The position will be responsible for...
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EH&S Specialist
4 weeks ago
Windsor, United States Mativ Full timeDescription Description:Our EH&S Specialist supports Mativ’s Sustainable & Adhesive Solutions Function. The EH&S Coordinator will provide environmental health and safety support to assigned operations and will ensure that all practices are in compliance with federal, state, and local laws, regulatory and ISO requirements. The position will be responsible...
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EH&S Specialist
4 days ago
Windsor, United States Mativ Full timeDescriptionDescription:Our EH&S Specialist supports Mativ's Sustainable & Adhesive Solutions Function. The EH&S Coordinator will provide environmental health and safety support to assigned operations and will ensure that all practices are in compliance with federal, state, and local laws, regulatory and ISO requirements. The position will be responsible for...
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Sr. Provider Network Development Specialist
4 days ago
Windsor, United States Southern New England Healthcare Full timeJob DescriptionJob DescriptionThe Provider Network Development Specialist reports to the Director of Network Management with accountability for recruiting providers to join SoNE Health’s participating provider network. The Provider Network Development Specialist initiates, negotiates and executes participating provider agreements for SoNE.Job...
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Insurance Service Specialist
2 months ago
Windsor, United States Great American Insurance Group Full timeAlternative Distribution provides small commercial insurance solutions through four digital channels: 1) direct-to-customer through its platform, Policysweet.com; 2) through its co-brandable agent interface, PolicySweet for Agents; 3) through API connections with agent-owned quoting platforms; 4) through embedded offerings on other digital platforms. Its...
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Insurance Service Specialist
1 month ago
Windsor, United States Great American Insurance Group Full timeAlternative Distribution provides small commercial insurance solutions through four digital channels: 1) direct-to-customer through its platform, Policysweet.com; 2) through its co-brandable agent interface, PolicySweet for Agents; 3) through API connections with agent-owned quoting platforms; 4) through embedded offerings on other digital platforms. Its...
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Insurance Service Specialist
1 month ago
Windsor, United States Great American Insurance Company Full timeBe Here. Be Great. Working for a leader in the insurance industry means opportunity for you. Great American Insurance Group's member companies are subsidiaries of American Financial Group. We combine a "small company" culture where your ideas will be heard with "big company" expertise to help you succeed. With over 30 specialty and property and casualty...
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Pipette Specialist
2 days ago
East Greenbush, United States Regeneron Pharmaceuticals Inc. Full timeWe are currently looking for a Pipette Specialist to join our Calibration team within the Process Maintenance group. In this business-critical role you will lead our pipette program, working closely with end users. You will be responsible for supporting all aspects of pipette calibration, repair, and scheduled maintenance. In this new role, ensuring...
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Peer Recovery Specialist, START Program
2 weeks ago
East Orange, United States The Center for Great Expectations Full timeJob Type Full-time Description Peer Recovery Specialist, START Program Support for mothers with substance use disorders and their children in the community Monday-Friday, 9am-5pm with flexibility in the evenings as needed for recovery meetings Under the supervision of the Site Manager, the Peer Recovery Specialist is responsible for outreach to...