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...
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. ...
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. ...
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,...
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...
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...
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. ...
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. ...
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...
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...
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...
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 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...
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...
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...
It is not a lab-based role, but rather a corporate 'desk job' supporting regulatory registration for global product launches. ...
Coordinate with the team to monitor the progress of certain products submitted by Ostend Regulatory Affairs departments. Coordinate regulatory activities with internal teams and external regulatory agencies. Manage the day-to-day activities of less senior Regulatory Affairs professionals, including ...
The 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. A minimum of 4 years in IV...
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...
Utilize DHS NSCD-authorized compliance tracking system(s) tool to track approvals, compliance activities, and reporting. Specialist should be capable of providing security control assessments in accordance with NIST Risk Management Framework and the Committee on National Security Systems (CNSS)&rsqu...
The Regulatory Affairs (RA) Associate Director, Labeling will be responsible for labeling activities across programs and stages of development, with specific responsibility for the United States and the Americas and supporting global needs as required. The RA Associate Director, Labeling will be ove...
Our Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and ...
Manages team and leads Regulatory Associates and/or Senior Regulatory Associates in regulatory activities associated with planning, authoring, compiling and submitting highest-quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicab...
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...
Assistant project managers may be assigned to work with a Project Manager depending on the program or project requirements. The project manager provides critical leadership and management in the execution of Engineering, Procurement and Construction of turnkey projects (EPC). Functions include progr...