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Regulatory Affairs Specialist
6 days ago
Hologic Newark, United StatesHologic is seeking a **Regulatory Affairs Specialist** to join our expanding Innovation Center located in Newark, DE. · **What to Expect**: · The **Regulatory Affairs Specialist **is expected to perform the coordination and preparation of document packages for regulatory submissi ...
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United Nations New York, United States**Job Opening** · **Job Opening ID**: 232130 · **Job Network** : Political, Peace and Humanitarian · **Job Family** : Humanitarian Affairs · **Category and Level** : Professional and Higher Categories, P-3 · **Duty Station** : NEW YORK · **Department/Office** : Office for the Coo ...
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Regulatory Affairs Specialist
1 week ago
Symrise Saddle Brook, United States**About Us** · Symrise is a global supplier of fragrances, flavors, food, nutrition, and cosmetic ingredients. Its clients include manufacturers of perfumes, cosmetics, food and beverages, pharmaceuticals and producers of nutritional supplements and pet food. · Its sales of € 4.6 ...
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Regulatory Affairs Specialist
1 week ago
BioTalent New York, United StatesPosition Summary · The primary responsibility of the Regulatory Affairs Specialist is to manage and perform regulatory submissions for local and worldwide regulatory agencies. The RAS is also responsible for ensuring products and procedures comply with regulatory agency specifica ...
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Regulatory Affairs Specialist
1 week ago
ACE Partners New York, United StatesMy client are looking for a Regulatory Affairs Specialist with experience in Asia Pacific Product Registrations. · You · MUST · be willing to work hybrid in office at Exton, Pennsylvania. · Essential Duties and Responsibilities: · Author and review China, South Korea, Japan a ...
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Regulatory Affairs Specialist
1 week ago
Nihon Kohden New York, United StatesThe Regulatory Affairs Specialist temp is responsible for developing and influencing regulatory policy and determining and pursuing courses of action necessary to obtain regulatory approval for the organization's products. Work with RA Leadership and other members of the RA team ...
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Public Affairs Specialist
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Fairstead New York, United StatesJob Description · Job DescriptionDescription:The Public Affairs Team seeks a Public Affairs Specialist to join our team. The Specialist will have an opportunity to engage in all aspects of Fairstead's work, including development, property management, asset management and corporat ...
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Regulatory Affairs Specialist
1 week ago
Katalyst Healthcares and Life Sciences Hoboken, United StatesResponsibilities Responsible for the coordination and preparation of document packages for regulatory submissions from all areas of the Company. · Keeps abreast of regulatory procedures and changes. · Coordinates the collection of documents, records, reports, and data from the ...
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Senior Regulatory Affairs Specialist
1 week ago
ACE Partners New York, United StatesOur customer is looking for a Senior Regulatory Affairs Specialist to join a team of 7 and supporting the product submissions, regulatory guidance, and registering products. · Duties Include: · Maintain and establish regulatory functions for medical device and environmental comp ...
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Regulatory Affairs Specialist III
1 week ago
PSG Global Solutions New York, United StatesWe're looking for a · Regulatory Affairs Specialist III , working in · Pharmaceuticals · and · Medical Products · industry in · Bridgewater, New Jersey, United States . · Contributes to the development and oversees the successful · implementation of regulatory strategies f ...
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Regulatory Affairs Specialist Ii
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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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VP, Regulatory Affairs Specialist
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Jefferies Jersey City, United StatesJob Description · Regulatory Affairs Specialist · Position · This hire will be a member of the Firm's Regulatory group which is responsible for exam oversight, branch inspections, regulatory change tracking, governance related tasks and additional ad-hoc tasks. The Firm's Regul ...
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Regulatory Affairs Specialist
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BPL Plasma Fort Lee, United States**Position** : Regulatory Affairs Specialist · **Location** : Fort Lee, NJ · **Duties and Responsibilities:** · 1. Ensures Regulatory compliance within KEDPLASMA organization to cGMP, Standard Operating Procedures and other applicable Standards and Protocols to meet the regulator ...
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Regulatory Affairs Specialist
1 week ago
Symrise AG Saddle Brook, United StatesThe Regulatory Affairs Specialist (F&B) will be responsible to independently provide Symrise Inc. customers with product safety/regulatory information in accordance with US FDA / FEMA guidelines, customer specific guidelines, and various internationa Regulatory Affairs, Specialis ...
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Regulatory Affairs Specialist
1 week ago
Symrise Saddle Brook, United StatesSymrise is a global supplier of fragrances, flavors, food, nutrition, and cosmetic ingredients. Its clients include manufacturers of perfumes, cosmetics, food and beverages, pharmaceuticals and producers of nutritional supplements and pet food. · Its sales of · 4.6 billion in th ...
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Regulatory Affairs Specialist
1 week ago
Axelon Valhalla, United StatesJob Title : Regulatory Affairs Specialist · Shift hours : Monday - Friday 8AM To 5PM. · Job Location : Valhalla, NY · Pay: $28/hr · Job Description: · This Regulatory Affairs Specialist contractor position supports US Beverages Regulatory Affairs initiatives. The person in this p ...
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Regulatory Affairs Specialist
6 days ago
Symrise Saddle Brook, United StatesAbout Us · Symrise is a global supplier of fragrances, flavors, food, nutrition, and cosmetic ingredients. Its clients include manufacturers of perfumes, cosmetics, food and beverages, pharmaceuticals and producers of nutritional supplements and pet food. · Its sales of € 4.6 bi ...
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Regulatory Affairs Specialist
6 days ago
Axelon Valhalla, United StatesJob Title : Regulatory Affairs Specialist (US Beverages) · Contractor · Shift hours : Monday - Friday 8AM To 5PM. · Job Location : Valhalla, NY · Pay: $28/hr · Job Description: · This Regulatory Affairs Specialist contractor position supports US Beverages Regulatory Affairs ...
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Regulatory Affairs Specialist
17 hours 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 Specialist - Phar ...
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Regulatory Affairs Specialist
1 week 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 ...
Regulatory Affairs Specialist - New York, United States - Kelly Science, Engineering, Technology & Telecom
Description
Kelly Science & Clinical is seeking aRegulatory Affairs Ops Specialist near Round Lake, IL.
Long term contract = ~1 year contract
Shift:
Monday - Friday 1st
Hybrid - 3 days onsite, 2 remote
Compensation :
based on experience
Responsibilities:
Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, AdProm, and other electronic submission types
o Creating timelines for regulatory filings
o Providing and maintain templates for authoring.
o Overseeing authoring and reviewing of regulatory documents
o QC submission documents
Contribute to the development of process improvements and procedural documents.
Identifying and assessing regulatory risks and risks to timelines.
Providing regulatory updates to the project team on different milestones.
Working cross functionally with project management, operations, IT and other functions.
Coordinate submission scheduling with regulatory publishing and ensures delivery of high-quality documents.
Working closely with other members of the Regulatory team and provide support to their projects as needed.
Maintaining archival of submissions and health authority communications in Veeva RIM system.
Provide regulatory representation on key meetings, including meetings with health agency.
Qualifications:
BA/BS in a scientific field and 2-4 years of proven experience
Solid understanding and experience and interpretation of regulatory requirements, with particular emphasis on the US region.
Strong organization skills and the ability to track multiple timelines in parallel and manage deadlines.
Excellent written and verbal communication and ability to collaborate across functions.
Experience with Veeva Vault systems is preferred.
Strong team player, self-motivated and able to function independently as well as part of a team
Able to work on multiple projects concurrently and adapt to a continuously changing environment.