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. ...
Support daily Regulatory Affairs function eg; compliance to CFR ,, ISO requirements, Company policies, operating procedures, processes, promotional task assignments into windchill and assigned training. Provide Regulatory support in Manufacturing Plant Transition Project, Quarterly Management Review...
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. ...
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...
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...
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 ...
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...
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...
I look forward to hearing from you soonJob# 36317Job Title: Global Regulatory Affairs Documentation SpecialistLocation: Rahway, NJDuration: 12 months contract (Potential to extend)Benefits: Paid Sick Leave, Matching 401K and Health Insurance with minimum chargesFreyr is hiring for its direct client,...
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...
Support daily Regulatory Affairs function eg; compliance to 21 CFR 820,807,803 ISO 13485 requirements, Company policies, operating procedures, processes, promotional task assignments into windchill and assigned training. Provide Regulatory support in Manufacturing Plant Transition Project, Quarterly...
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...
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...
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...
In this role, the regulatory leader will be primarily responsible for the development of US regulatory strategies and have the role of Global Regulatory Strategist to advance Genmab’s portfolio of development and marketed drugs. Genmab is looking for an experienced and passionate leader to be ...
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...
Senior Director, Global Regulatory Affairs Strategy. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with regulatory agencies, and being responsibl...
Manager, Team Member Resource Group Programs & Impact - ERG. The Manager, TMRG Programs & Impact works with executive leadership, TMRGs, team members, local site equity councils, communications/marketing, HRIS team, DEI strategic community partners and other key stakeholders to drive transformative ...
Site Start-Up & Regulatory Specialist II. Local Submissions Specialist - Follows the project direction provided by the designated country start-up advisor (CSA) and SSUL. Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or h...
Manage ongoing program needs and suggest program improvements to further enhance learning program effectiveness and sustainability within Transformational Capabilities capability. Our prestigious, well respected client is seeking a L&D Program Manager, Content Transformation to complement their expa...
Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP's, and regulatory requirements. Accountable for all project deliverables for each project assigned. May participate in bid defense meetings where presented as p...
It is not a lab-based role, but rather a corporate 'desk job' supporting regulatory registration for global product launches. ...
Identifies issues to be pursued based on large, unusual or questionable items that produce a significant tax or compliance effect and utilizes the tax law and facts needed to resolve them. ...