- Aequor (Thousand Oaks, CA)
- …registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs ... Backfill of AMAGJP00011619 *100% REMOTE - Needs to support PST time zone...Regulatory Project Coordinator (RPC)Job Description: o Assist Regional Regulatory Representative to support regional regulatory activities… more
- Aequor (Thousand Oaks, CA)
- …all Functional areas, internal and external to GRAAS, local offices, external partners, and regulatory authorities. This will be a 100% remote role. The hiring ... do. Detail oriented, to be able to monitor data quality . Comfortable learning new systems/processes. Someone who is able...details, since we work so much with monitoring Data Quality and someone who is able to communicate clearly… more
- Merck & Co. (Rahway, NJ)
- …operations.Works in partnership internally with GCTO country operations, finance, regulatory affairs , pharmacovigilance, legal and regional operations, HQ ... problems include: 1) Issues in informed consent negotiations, 2) Quality and compliance issues 3) Regulatory and...individual has ability to work effectively also in a remote virtual environment with a wide range of people.Positive… more
- Merck & Co. (Rahway, NJ)
- …payment timelines.Works in partnership internally with GCTO country operations, finance, regulatory affairs , pharmacovigilance, legal and regional operations, HQ ... include: 1) Issues in budget / CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and...individual has ability to work effectively also in a remote virtual environment with a wide range of people.Positive… more
- Merck & Co. (North Wales, PA)
- …divestment and product withdrawal.Support new technology development.Demonstrate an understanding of regulatory affairs and applies this understanding to the ... for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance… more
- Merck & Co. (Rahway, NJ)
- …and devices. The Executive Director, as a senior member of the Global Regulatory Affairs and Clinical Safety: Chemistry, Manufacturing and Controls Organization ... is pivotal in fostering alignment and global execution across Regulatory Affairs , R&D, Manufacturing, and our Commercial...are in place to maintain the scientific, technical and regulatory quality of all CMC submissions, correspondence,… more
- Merck & Co. (Rahway, NJ)
- …needed.Works in partnership internally with GCTO country operations, finance, regulatory affairs ,-pharmacovigilance, legal and regional operations, HQ functional ... with ICH/GCP and country regulations, company policies and procedures, quality -standards and adverse event reporting requirements internally and externally.Acts as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …key stakeholder interactions include: Research and Early Development / Development / Global Regulatory Affairs / Global Safety / Local affiliates / Suppliers ... Department Every day, millions of people rely on the quality and safety of our products. The Novo Nordisk...up-to-date knowledge of legislation, guidance and general interpretation from regulatory sources, as well as relevant changes in industry… more
- Merck & Co. (North Wales, PA)
- …and systems for a pharmaceutical company, ensuring compliance with regulatory requirements and maintaining high- quality standards.-Product managers must ... cross-functional teams to develop and implement pharmacovigilance strategies that meet regulatory requirements and ensure patient safety, quality and… more
- Merck & Co. (Rahway, NJ)
- …(eg, CCDS, CCPPI, CCIFU) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU Labeling ... regulatory labeling point of contact on global Regulatory Affairs sub-teams to ensure delivery of...sub-teams to ensure delivery of labeling documents that meet quality and compliance standards and regulatory labeling… more
- STERIS (Alpharetta, GA)
- Senior Manager, Regulatory Affairs Biocides - Remote Req ID: 41369 Job Category: Regulatory Affairs Alpharetta, GA, US, 30004 Description: At STERIS, ... around the globe. Position Summary The mission of the Regulatory Affairs group is to implement effective...BPR and other international markets. + Home Based / Remote opportunity + 20% Domestic Travel Required + 10%… more
- Battelle Memorial Institute (MA)
- …Healthcare innovation is at the core of what we do. Join Battelle as the Regulatory Affairs Director where you will lead and drive the organization's ... regulatory affairs strategy for our Health Business...operations in **_Columbus, OH; Boston, MA_** but may be remote . **Major Responsibilities** + Direct all regulatory … more
- Kelly Services (Venice, FL)
- ** Regulatory Affairs Manager** **Hybrid/ Remote with up to 10-20% travel on site as needed** **Monday-Friday 8am-5pm, some hours outside of this time frame** ... **Position Overview:** As the Regulatory Affairs Manager, you will collaborate closely...13. ** Quality Assurance Collaboration:** 14. Collaborate with quality assurance teams to ensure adherence to regulatory… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Boehringer Ingelheim's high regard for our employees. The Associate Director, Global Regulatory Affairs Analytics and Performance is dedicated to strategically ... aligning Global Regulatory Affairs (GRA) objectives for all functions...drive relevant performance metrics are available and have sufficient quality . If not available, this role will be responsible… more
- AbbVie (Mettawa, IL)
- … Advertising Promotion safeguards products and practices to adhere to the highest quality and regulatory standards. Designs and delivers optimized global ... of pharmaceutical experience a minimum of 3 years advertising and promotion regulatory experience preferred but may consider medical/scientific affairs with a… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Ingelheim's high regard for our employees. The Associate Director, US Product CMC Regulatory Affairs is responsible for the coordination and execution of ... post marketing reports per US FDA regulations. The Associate Director, US Product CMC Regulatory Affairs acts as primary internal contact for all US … more
- Fresenius Medical Center (Waltham, MA)
- …be fully remote . **PURPOSE AND SCOPE:** Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product ... compliance. Develops, coordinates, reviews and prepares documentation packages for pharmaceutical regulatory submissions (Primarily US). May act as FDA liaison for… more
- Amgen (Thousand Oaks, CA)
- …science that can turn the tide of serious, life-interrupting illnesses. **Head of Regulatory Affairs Policy & Intelligence** **Live** **What you will do** Let's ... the world. In this vital role as Head of Regulatory Affairs Policy & Intelligence you are...Affairs Policy & Intelligence leads a team of remote professionals located in both the United States and… more
- Philips (Latham, NY)
- …requirements. Analyze and optimize RA processes together with cross-functional partners such as Quality Management, Regulatory Affairs , Clinical Affairs , ... **Senior Regulatory Affairs Specialist (US Hub based location)** The Senior Regulatory Affairs Specialist is responsible for regulatory compliance,… more
- System One (Deland, FL)
- Position: CONTRACTOR -- Director, US Regulatory Affairs & Global Development Projects (GDP) Location: Remote (East or Central Time Zone) / Prefers local ... Pay Rate: 80/hr - 95/hr Purpose and Scope of Position The Director, US Regulatory Affairs & Global Development Projects (GDP) is responsible for providing… more
