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 ...
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. ...
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...
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...
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...
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...
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...
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...
A Manager is responsible for activities related to regulatory publishing and submission support to FDA and other regions accepting eCTD. Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications. Supports...
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...
It is not a lab-based role, but rather a corporate 'desk job' supporting regulatory registration for global product launches. ...
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...
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...
Regulatory Affairs Manager - Permanent - Bridgewater, NJ. Proclinical is seeking a Manager, Regulatory Affairs for a global medical device company. The Manager, Regulatory Affairs will:. Leads regulatory resources to ensure timely product registrations, regulatory planning for new product introducti...
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 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...
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...
Bull City Talent Group's direct client has an immediate need for an IT Infrastructure Project Manager to assist with the move/buildout of one of their Data Centers. The ideal resource will have 8+ years of IT Infrastructure PM experience, have led multiple projects involving the move/buildout of Dat...
Write Regulatory documents translating team strategy into regulatory overview documents such as cover letters, pre-meeting package, and other US specific regulatory positioning documents to assist Project Leaders in support of business needs. Develop and maintain positive rapport and working relatio...
Our client, a growing pharmaceutical company, has engaged GForce to provide a CMC Regulatory Affairs Manager Consultant. The role will be focused on providing CMC regulatory strategy input and expertise around investigational, new, and marketed biologic and small molecule drug products to assigned p...