Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society. Compile, prepare, and review regulatory submission to US and EU. Anticipate regulatory obstacles and emerging issues throughout the product submission. Provide regulatory input for responsible countries/region fo...
Internal Job Title: Regulatory Affairs Associate II. Position requires a Bachelor's degree in a science or chemistry-related field, coursework or certification in Cosmetic or Drug Regulatory Affairs. Canada Chemical regulatory oversight and review. ...
Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business. Represent RA on pro...
Senior Principal Regulatory Affairs Specialist. 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,...
Maintains advanced and current knowledge of relevant regulations, policies, and guidelines and acts as Regulatory Affairs Subject Matter Expert in assigned areas. Provides guidance/direction within the regulatory department and stakeholder groups relative to regulatory compliance of client's product...
This person will be a Regulatory liaison between product development and the regulatory agencies. Experience with eCTD filings; Regulatory Affairs Certification (RAC). This position will be responsible for regulatory submissions for new ANDAs and any changes being made to existing products. Regulato...
Maintains advanced and current knowledge of relevant regulations, policies, and guidelines and acts as Regulatory Affairs Subject Matter Expert in assigned areas. Provides guidance/direction within the regulatory department and stakeholder groups relative to regulatory compliance of client's product...
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...
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 ...
Determine appropriate regulatory requirements and strategies for new product development projects including both domestic and foreign activities and provide regulatory consultation to other internal and external entities. Must make a proactive contribution to the overall Regulatory affairs departmen...
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. ...
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...
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...
Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization. Act as the US/Global Regulatory Leader (GRL) for assigned project(s) and be responsible for the development, implementation, and maintenance of US/global regulatory strategies...
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, review, and submission of regulatory packages to Client Medical, Legal and Regulatory (MLR) g...
Support daily Regulatory Affairs function eg; compliance to 21 CFR (phone number removed) ISO 13485 requirements, Company policies, operating procedures, processes, promotional task assignments into windchill and assigned training. Provide Regulatory support in Manufacturing Plant Transition Project...
Position requires a Bachelor's degree in a science or chemistry-related field, coursework or certification in Cosmetic or Drug Regulatory Affairs. Chemical regulatory oversight and review. ...
Regulatory Affairs Associate located in Clark, NJ. It is not a lab-based role, but rather a corporate 'desk job' supporting regulatory registration for global product launches. ...
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. ...
The Compliance Data Analyst I will report to the GRC Senior Compliance Associate, and assist with ongoing data remediation, data quality checks, license verification from respective state boards to ensure federal, state and EU disclosure reports are reported timely and accurately on behalf of OAPI a...
We are looking for an entry-level Regulatory Registration Assistant to join our Research & Innovation (R&I) team. This position is a corporate desk job focused on supporting regulatory registration for global product launches. ...
The Regulatory Affairs Manager will be responsible for ensuring compliance with all regulatory standards and guidelines, leading the preparation and submission of regulatory documents including CMC modules, and overseeing the development of generics including Risk Evaluation and Mitigation Strategie...
The Senior Associate, Regulatory Affairs is responsible for supporting applications under pre and post approval conditions. Under the direction of Regulatory Affairs management, participate in drug development from early stage development through final formulation, ensuring compliance with principle...
Position requires a Bachelor's degree in a science or chemistry-related field, coursework or certification in Cosmetic or Drug Regulatory Affairs. HM is looking for someone that has Canada and US artwork review experience, as well as notifying cosmetics in Canada - and a plus would be if they know h...
This position is responsible for second shift quality compliance support of manufacturing operations. Ensure sustainable compliance to all regulations related to area of oversight (e. Review/approve SOP’s, Reports, Equipment/Method Qualifications/Verifications/Validations, Excursions, specifications...