regulatory Jobs in chicago, il

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IT Business Relationship Manager - Quality, Regulatory and R&D

Abbott Laboratories

Lake Forest, Illinois, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future

Global Regulatory Strategist

Softpath System, LLC.

Remote

Third Party, Contract

Hi, Hope you are doing great.! My name is Rekha and I am a Staffing Specialist at Softpath System LLC. I am reaching out to you on an exciting job opportunity with one of our clients. Position: Global Regulatory Strategist Location: Remote Type: Contract JOB DESCRIPTION Liaison between Country Regulatory Managers and Global Regulatory Teams/Development Teams/Brand Teams/Operating Committees Responsible in partnership with local GRS for generating, implementing and executing regulatory strategy

Regulatory Affairs Specialist

AR Val Services

Remote

Contract

Responsible for the global coordination and the preparation of documents/packages for regulatory submissions. In this position you will also review and evaluate technical and scientific data and reports required for submission . Essential Duties and Responsibilities Supports regulatory project plan execution Maintain awareness of regulatory requirements and ensure continued learning Maintain regulatory files in a format consistent with requirements Participate as an active team member of projec

CMC 2 Regulatory affairs

Softpath System, LLC.

Remote or Rahway, New Jersey, USA

Contract, Third Party

Hi, Hope you are doing great.! My name is Rekha and I am a Staffing Specialist at Softpath System LLC. I am reaching out to you on an exciting job opportunity with one of our clients. Title: CMC 2 Regulatory affairs Location: Rahway, NJ - Onsite Type: Contract Responsibilities: Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with reference EU Member States Manage execution / authoring and review of CMC documentation (Module 1

CMC Regulatory Senior Manager

Digitive LLC

Remote

Contract

Regulatory & Medical Affairs - Regulatory Studio - CMC Senior Manager Location: RemoteVertical- Life sciences Contract Job Description: PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred. Responsibilities will include, but are not limited to, the following: 1. Participate in the development of the CMC regulatory strategy for

Global Regulatory Strategist

Softpath System, LLC.

Remote

Third Party, Contract

Title: Global Regulatory Strategist Location: Remote Type: Contract Job Description: Position Summary / Objective Liaison between Country Regulatory Managers and Global Regulatory Teams/Development Teams/Brand Teams/Operating CommitteesResponsible in partnership with local GRS for generating, implementing and executing regulatory strategy and submission plans for development and life cycle products for the regionProvides regional input into Global Regulatory Plan and Global Submission PlanProvid

CMC Regulatory Affairs Manager

TechSpace Solutions Inc.

Remote

Third Party, Contract

Job Title : CMC Regulatory Affairs Manager Location :Remote Duration : 12 Months Job Description: Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reportsExperienced in authoring of assessment reports and Part2/ Expert reports for DossiersExperience in reviewing of quality documents such as Reformulation studies, process validations, particle size method implementation and specification, stability indicating methods implem

Global Regulatory Strategist@Remote

HUMAC INC.

Remote

Contract

Global Regulatory Strategist Location: Remote JOB DESCRIPTION Position Summary / Objective Liaison between Country Regulatory Managers and Global Regulatory Teams/Development Teams/Brand Teams/Operating Committees Responsible in partnership with local GRS for generating, implementing and executing regulatory strategy and submission plans for development and life cycle products for the region Provides regional input into Global Regulatory Plan and Global Submission Plan Provides information and p

Principal Regulatory Affairs Specialist (remote)

Medtronic

Remote or Los Angeles, California, USA

Full-time

Careers that Change Lives Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's w

Senior Regulatory Affairs Specialist (Medical Devices)

ApTask

Remote

Contract

Job Title: Senior Regulatory Affairs Specialist (Medical Devices) Location: Remote Duration: Long term contract Job Description: -Subject Matter Expert for Class II and Class 510(K) submission. -Hands on experience with 510(k) authoring, submissions, and communicating with the FDA. -Hands on experience with software as a Medical Device (SaMD) and validation requirements and applicable consensus standards. Key Responsibilities- -Authoring US FDA 510(k) submission using eSTAR submission tool.

Principal Regulatory Affairs Specialist (Remote)

Medtronic

Remote or Los Angeles, California, USA

Full-time

Careers that Change Lives Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's w

SAP PRA Consultant (Regulatory Reporting)

Activesoft, Inc.

Remote

Contract, Third Party

SAP PRA Consultant (Regulatory Reporting )Occasional Travel to Houston TXJob Description:1) Revenue Accounting and Disbursement 2) Production Accounting :Gas Booking and contracting, allocation, Well level accounting for production 3) Regulatory Reporting govt and federal agency including annual reporting.