- PharmaOur team in South Plainfield currently has an opening for a Regulatory Affairs Specialist
- PharmaYOUR ROLE & RESPONSIBILITIESSupporting the regional Pharma division Sales Team on topics including regulatory, legal, compliance, quality and product safety.
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Regulatory Affairs Specialist Ii
1 week 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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Regulatory Affairs Specialist
5 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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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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Specialist - Regulatory Affairs
1 week 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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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
6 days ago
Katalyst Healthcares and Life Sciences South Plainfield, United StatesResponsibilities: Provides administrative support for regulatory affairs manager · Provides RA support for change control projects and sustaining activities · Conducts regulatory assessments and determines need for re-registration for proposed device changes, prepares internal ...
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Regulatory Affairs Specialist
2 days ago
Reliance Private Label Supplements Edison, United StatesJob Description · Job DescriptionPOSITION SUMMARY: · Responsible for all aspects of the documentation process including the label/supplement facts panel (SFP) development, review and implementation of dietary supplement labels for private label, branded and contract formulations ...
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Regulatory Affairs Specialist
6 days 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
6 days 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
6 days 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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Specialist - Regulatory Affairs
6 days 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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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
6 days ago
Kelly Science, Engineering, Technology & Telecom New York, United StatesKelly Science & Clinical is seeking a · Regulatory 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 pre ...
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Regulatory Affairs Specialist
6 days 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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Regulatory Affairs Specialist
5 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
2 days ago
Katalyst HealthCares & Life Sciences Short Hills, United StatesResponsibilities: · Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reports · Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers · Experience in reviewing of quality do ...
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Regulatory Affairs Specialist
2 weeks ago
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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Regional & Community Affairs Specialist
1 week ago
Con Edison Staten Island, United StatesRegional & Community Affairs Specialist · Job Info · 112202 · Posting Expiration Date:Jun 30, 2024 · Schedule Type:Full-Time · Minimum Salary:$80000 · Maximum Salary:$100000 · Organization:Government Regional& Comm Affs · Department:NYC Regional&Community Affairs · Section:REG CO ...
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Regulatory Affairs Specialist
4 days ago
Adecco Morris Plains, United StatesAdecco Creative and Marketing is partnering with an American multinational beauty company. We are searching for a Compliance Analyst for a 6 month hybrid assignment in Morris Plains, NJ. This person would be responsible for cosmetic regulatory compliance on the global team. · Job ...
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Public Affairs Specialist
1 day ago
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 ...
Regulatory Affairs Specialist - Iselin, United States - Brenntag
Description
Stage Picture:
brenntag_other_8.
jpgJobTitle:
Regulatory Affairs Specialist - PharmaLocation:South Plainfield/USA
Employment Type:
EmployeeRegulatory Affairs Specialist
Completion of technical and regulatory information requests from customers within the pharmaceutical industry (questionnaires, supply chain agreements, QAA's & TA's) in and English.
Contribute as part of team to maintenance of EMEA document management system to keep product and supplier information up to date.
Request product and supplier information directly from manufacturers and indirectly via other internal channels.Process Change Control Notifications.
Maintain customer specific information such as completed questionnaires, supply chain agreements, QAA's, TA's in the designated database.
Creation and ongoing update of product regulatory information in standardized information packs. Support of customer, regulatory and 3rd party audits.
Reporting and documenting customer requests via KPIs.
YOUR PROFILEEducation and Experience:
2 years previous experience working with regulatory documentation.
Knowledge of ISO9001, food safety or GxP systems.
University degree in life sciencesKnowledge of pharmaceutical industry requirements and regulations on APIs, Excipients and starting materials.
Previous experience with the FDA (or another national competent authority) and their requirements.
Team player, strong communication and interpersonal skills, with ability to work across all levels, and functionsOUR OFFERWe aim to create anenvironment where the best people want to work, where they can turn theirpassion into their job and realize their full potential.
Individual development,on-the-job training, and development programs designed to help ouremployees grow in their careers.Competitive pay andincentives.
Various healthcare planoptions as well as 401(k).INTERESTED?We look forward receiving your application.
Brenntag provides equalemployment opportunities to qualified applicants and employees without regardto race, color, religion, sex, sexual orientation, gender identity, nationalorigin, protected veteran status, disability or any other status protected byapplicable federal, state or local law.
Brenntag North America, Inc.and its subsidiaries useE-verify, a government-run, web-based system that allows employers to confirmthe eligibility of their employees to work in the United States.
For moreinformation, please go to https:
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