The Regulatory Analyst advises R&D, global procurement, and business teams on the safe use, regulatory compliance, and labeling of food ingredients. ...
To ensure that all Flavor, Fragrance & feed formulations comply with industry, Federal/State, Global/International Regulatory bodies and customer requirements. Assist with Regulatory Database and Systems maintenance including but not limited to:. Coordinate, prepare and review regulatory documents/c...
Specialist for Regulatory Affair s is responsible for regulatory activities including submission, operational and compliance for US-licensed products and additional project/s assigned. Responsibilities include:As the US Product Owner (USPO), responsible for the maintenance of the US dossiers and the...
Assist the Manager of Regulatory Affairs during cGMP, Environmental, and Regulatory audits. Assist the Manager of Regulatory Affairs during periodic quality reviews, regulatory updates, and annual GMP training. Regulatory Affairs Manager with inspections and audits, ensuring compliance. The speciali...
Position Objectives:Responsible for the overall product strategy, reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance, regulatory intelligence and change management for consumer products (Rx/OTC, OTC Monograph, Nutritional, and Cosmetics)...
Regulatory expert support IVDR teams, implements regulatory strategies for IVDR activities; provides regulatory leadership; collaborates with the regulatory staff from other business units, companies, government agencies as needed to develop harmonized policies, procedures and work instructions for ...
Day to Day they will be working w the ingredient team ( ppl) as well as the larger regulatory team to perform the below activities - will have coaching and guidance as they will be more entry level - years of experience. Regulatory Analyst with emphasis on ingredients. This role advises the R&D, glo...
Reports to: Manager, Environmental, Health, Safety & Security (EHSS)MAIN PURPOSE (Briefly state the job's overall objective)Provides product stewardship, regulatory, and sustainability support and expertise to business units for complying with EHSS global regulatory requirements. S and international...
They engage in correspondence, meetings, and interactions with the FDA to address regulatory inquiries, respond to requests for additional information, and seek clarification on regulatory matters under the guidance of the Director, US Market Access. Analyzes and communicate the adequacy of proposed...
The Regulatory Affairs Senior Specialist will manage regulatory compliance and submissions to ensure that all products follow federal regulatory guidelines. Regulatory Affairs Senior Specialist. Responsibilities of the Regulatory Affairs Senior Specialist:. The Regulatory Affairs Senior Specialist w...
Regulatory Affairs Specialist III. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. Prepare responses to customer requests for information, such as produc...
Regulatory Affairs Specialist Project Lead I (Scientific). This role will be accountable for leading the development and execution of innovative and value-added global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS) for immunology products in Ea...
This position is responsible for the preparation of regulatory submissions required to market medical devices in both the and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the pr...
This role will be accountable for leading the development and execution of innovative and value-added global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS) for immunology products in Early Development. At least 8-10 years of relevant pharmaceut...
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. Gathering, generating, and managing ...
Administer regulatory change program review of vendor tools/applications available for regulatory change monitoring oversee selection/implementation/administration of vendor tool/application if warranted summarize and distribute new/amended rule proposals and rules to internal constituents oversee i...
Regulatory Affairs Specialist I. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. Prepare responses to customer requests for information, such as product ...
The requirement is for 3 Regulatory Affairs Specialist. The candidates will work with client & Our client's teams to deliver best in-class solutions for regulatory submissions. Facilitate worldwide product registration activities by compiling appropriate dossiers, submissions and responses to regula...
Summary: Regulatory Analyst with emphasis on ingredients. This role advises the R&D, global procurement and businesses on the safe use, regulatory compliance, and labeling of food ingredients. This includes reviewing all ingredients purchased by the company, with consideration of how they are manufa...
Prepare new and maintain existing regulatory files in accordance with regional requirements, including but not limited to document updates, management of regulatory information in databases, and navigating document control systems. Review regulatory content for completeness, accuracy, consistency, a...
Prepare new/revised label packaging for regulatory submissions to the USDA and maintain regulatory documents to ensure site compliance. Support regulatory filing submissions with the USDA for both domestic and international product packaging. ...
Summary: The Regulatory Analyst advises R&D, global procurement, and business teams on the safe use, regulatory compliance, and labeling of food ingredients. Responsibilities:Regulatory Documentation and Systems:Compile and maintain regulatory documentation databases or systems. Regulatory Submissio...
Job Title; Regulatory Affairs Specialist. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. Prepare responses to customer requests for information, such as...
Regulatory Affairs Specialist (Hybrid) . Kelly® Science & Clinical is seeking a Regulatory Affairs Specialist for our client in Bridgewater, New Jersey. Experience in Regulatory Affairs preferably Medical Devices, preferably on Global programs. Provide Regulatory Documentation Support to G...
Senior Staff Regulatory Affairs Specialist. As the Senior Staff Regulatory Affairs Specialist, you will work to maintain medical devices on the market and ensure ongoing compliance. You will participate on cross-functional teams, develop global regulatory strategies, author regulatory submissions, i...