A company is looking for an Associate Regulatory Operations Specialist (Remote). ...
CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compl...
A company is looking for a Principal Regulatory Affairs Specialist, US Regulatory Policy. FDA regulatory requirements and policyRegulatory experience within the medical device industry or a regulatory agencyExperience in advocacy related to healthcare policy and regulationsStrong research and analyt...
This role will serve as a regulatory liaison to internal and external investigators, sponsors, collaborating divisions, departments and institutions, and Institutional Review Boards (IRBs), Data Safety and Monitoring Boards, Biosafety committees, Laboratory facilities, and external regulatory agenci...
A company is looking for a Regulatory Sales Specialist to manage sales opportunities in the regulatory compliance sector of financial services. Key Responsibilities:Maintain knowledge of the regulatory environment and SEC focus areasBuild relationships with prospects and clients to foster trust and ...
We're seeking a detail-oriented Regulatory Specialist to ensure regulatory compliance and support product development. This role ensures packaging and labeling meet regulatory standards, supports product development, manages costing and pricing, and collaborates cross-functionally for successful pro...
The Regulatory Affairs Specialist Project Lead I will oversee and manage regulatory projects with a focus on US FDA Advisory Committee (ADCOM) preparation. Job Title: Regulatory Affairs Specialist Project Lead I. ...
Job Title: TSCA/Environmental Specialist Location. ...
GGG is seeking a detail-oriented and self-motivated Food Regulatory Labeling professional to join our team in the Paramus, NJ office. ...
We're seeking a detail-oriented Regulatory Specialist to ensure regulatory compliance and support product development. This role ensures packaging and labeling meet regulatory standards, supports product development, manages costing and pricing, and collaborates cross-functionally for successful...
The role assists the Regulatory Manager and other associates within the Regulatory Department and works internally with Product Development, Sales/Customer Service and other internal functional areas to ensure the timely submission of the Regulatory documentation and compliance, and to support busin...
Hiring - Senior Regulatory Affairs Specialist. Assess applicable change requests for regulatory impact and follow-up on related regulatory action items. Support marketing, R&D and Lonza BU in ad hoc projects, in relation to market growth and innovation initiatives by preparing US regulatory assessme...
Catalent Pharma Solutions in Somerset, NJ is hiring a Senior Regulatory and Compliance Specialist for the Compliance Group. The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry and their impact on manufacturin...
The Senior Specialist is responsible for developing CMC regulatory submission strategies and timelines for assigned pharmaceutical projects/products in accordance with global regulations and guidance. The Senior Specialist is also responsible for the preparation and review of information required fo...
Provides guidance/direction within the regulatory department and stakeholder groups relative to regulatory compliance of client's products and processes. Independently support data maintenance and archival and retrieval of regulatory documentation in computerized systems. Assist with preparing high ...
Summary/Objective: GGG is seeking a detail-oriented and self-motivated Food Regulatory Labeling professional to join our team in the Paramus, NJ office. ...
As a Quality & Regulatory Affairs Specialist (m/w/d), you will be in charge of providing support to Capital Equipment servicing as well as to EMEA Quality and Regulatory Organisation to ensure quality and regulatory compliance. ...
The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry (or regulated industry equivalent) and their impact on manufacturing processes and practices. This role has high visibility within the Somerset site and the...
The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry (or regulated industry equivalent) and their impact on manufacturing processes and practices. This role has high visibility within the Somerset site and the...
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 Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry (or regulated industry equivalent) and their impact on manufacturing processes and practices. This role has high visibility within the Somerset site and the...
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 for product lifecycle planning. Monitor applications under regulatory review and communica...
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...
Implements regulatory activities such as obtaining global regulatory clearances and/or approvals, preparing device listings, performing import/export requirements, fulfilling regulatory compliance obligations, and maintaining regulatory intelligence. The Regulatory Affairs Specialist coordinates, fa...
We're seeking a detail-oriented Regulatory Specialist to ensure regulatory compliance and support product development. This role ensures packaging and labeling meet regulatory standards, supports product development, manages costing and pricing, and collaborates cross-functionally for successful pro...