Hybrid Senior Manager, Regulatory Affairs - Lincolnshire, IL, United States

We are seeking a Regulatory Affairs Associate to support U.S. and global regulatory submissions for medical device products.This role will assist in executing global regulatory strategies, · preparing and maintaining registration dossiers, · and ensuring compliance with FDA,EU,an ...

We are seeking an experienced Regulatory Affairs Associate II to join our team. The successful candidate will have direct medical device regulatory experience with recent hands-on EU MDR 2017/745 experience. · ...

We are seeking a Regulatory Affairs Specialist to provide regulatory support and expertise for U.S. and global medical device submissions. · Provide regulatory support for U.S. and global submissions, including analysis of requirements and tracking deliverablesAssist with executi ...

Provide regulatory support and expertise associated with US and global submission requirements. · ...

The job is to work as a Regulatory Affairs Associate II in Lake Forest, IL 60045 for 12 months. The job requires a Bachelor's Degree preferably in pharmacy or related subject and RAC Certification. · Proven strong understanding of FDA and worldwide submission requirements. · Prep ...

Provide regulatory support and expertise associated with US and global submission requirements. · ...

Provide regulatory support and expertise associated with US and global submission requirements. · ...

We are seeking a Regulatory Affairs Associate to join one of our leading healthcare clients. · The Regulatory Affairs Associate (Contract) will support Regulatory Operations by assisting with operational activities within regulatory projects. · ...

We are seeking a Regulatory Affairs Associate to join one of our leading healthcare clients. · ...

The Principal Regulatory Affairs Manager is responsible for regulatory strategy development and execution for high-complexity diagnostics specifically Companion Diagnostics and digital pathology in the clinical oncology environment. · The Principal Regulatory Affairs is responsib ...

The Principal Regulatory Affairs Manager will lead global submission work for CDx trials and submissions to support product commercialization in multiple regions. They will mentor the organization on key activities and develop regulatory strategies for external partnerships and p ...

The Director Regulatory Affairs is responsible for implementing regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching regulatory strategy and brand plan. · As a qualified candidate, you must possess a bachelor's d ...

The Regulatory Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain global regulatory approvals. · ...

Under general supervision works to ensure products and processes meet all applicable state federal local regulations and industry best practices for distribution of regulated products food pharmaceuticals or medical devices. · ...

The Regulatory Affairs Associate (Contract) will support Regulatory Operations by assisting with operational activities within regulatory projects. ...

Under general supervision the Regulatory Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain global regulatory approvals. · ...

This role will work within an Export Regulatory and Quality team. This position will be responsible for reviewing nutrition and regulatory compliance and providing support in the Quality area related to client products globally. · Provide technical information and evaluating regu ...

The Regulatory Affairs Associate I supports regulatory submission activities for marketed pharmaceutical products. · Author, compile, and manage CMC sections (CTD Module 3) for marketed product variations. · Ensure regulatory documents meet structural, formatting, and content req ...

The Regulatory Affairs Associate will be responsible for managing and compiling regulatory submissions for marketed product variations. · Manage, compile, and author CMC sections for marketed product variations · Partner with RA CMC Project Leads to develop Module 3 content · ...

The Regulatory Affairs Associate I supports regulatory activities for marketed products with a focus on chemistry manufacturing and control documentation. · ...