Regulatory Affairs Associate II - Lake Forest, IL

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. · ...

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. · +Drives projects forward and executes agreed upon strategies. · Plans registration packages for device products. · ...

We are hiring Regulatory Affairs Associate II for one of our clients. · Provide regulatory support and expertise associated with US and global submission requirements. · ...

This role provides regulatory support and guidance associated with global and US registration of device products. · Drives projects forward and executes agreed upon strategies and plans with oversight. · Maintains awareness of applicable regulations. · Plans and organizes registr ...

Job summaryThe Associate II provides regulatory support and guidance associated with global and US registration of device products. · Maintains awareness of applicable regulations. · Evaluates manufacturing and labeling changes for regulatory impact. · ...

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 I supports regulatory submission activities for marketed pharmaceutical products. · The position requires strong coordination skills and attention to detail. ...

This position will coordinate activities with all functional departments in support of regulatory filings. · Manage and compile CMC sections of marketed product variations. · Partner with RA CMC Project Leads and develop module 3 content and project timelines. · ...

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

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 · ...

This role is responsible for managing, authorizing and compiling Chemistry, Manufacturing and Controls (CMC) documentation for marketed product variations and regulatory submissions. The position partners closely with cross-functional teams to ensure CMC sections meet regulatory ...

+Job summary · Responsible for managing the activities for marketed product variations including authorizing and compiling of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents. · This position will coordinate activities with ...

The Regulatory Affairs Associate I is responsible for managing activities related to marketed product variations. · ...

The Regulatory Affairs Associate I is responsible for managing activities related to marketed product variations. · ...

+The Regulatory Affairs Associate I is responsible for managing activities related to marketed product variations,+ · ++Manage and compile CMC sections of marketed product variations.+Partner with RA CMC Project Leads to develop module 3 content and project timelines.+Collaborate ...

This Regulatory Affairs Associate I position offers a dynamic opportunity for a detail-oriented professional to make a significant impact on both pharmaceutical and medical device regulatory lifecycles. · This role is designed for a proactive communicator who thrives on cross-fun ...