- Integra LifeSciences (Princeton, NJ)
- …functionality and applicable regulatory requirements. Leverage this knowledge to support regulatory processes, ensure data integrity within the system and ... patient outcomes and set new standards of care. The regulatory operations specialist position provides support across...associated systems , and… more
- Hologic (Newark, DE)
- …high-level regulatory support and guidance + Maintain and improve regulatory databases, tracking, and control systems + Recommend and implement process ... Affairs team, you will be responsible for the ongoing support , maintenance, and continuous improvement of regulatory ...in compliance processes + Proficiency with MS Office and regulatory document management systems + Experience with… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …process. + Collaborate with cross-functional subject matter experts to identify documentation to support responses to regulatory agency inquiries. + Act as a ... a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas...product specific submission packages to global health authorities to support business needs in a very timely and accurate… more
- BeOne Medicines (San Mateo, CA)
- … systems + Project Management Tools: Microsoft Project or Smartsheet + Regulatory Information Management (RIM) Systems (Veeva Vault, Liquent InSight, etc.) + ... **General Description:** The Senior Director of Global Regulatory Project Management is a pivotal leadership role...and retain top talent; set clear performance objectives and support career growth. + Partner with cross-functional leaders to… more
- Tecomet (Manchester, NH)
- …and regulatory compliance of supply chain partners; + Lead and support regulatory submissions, certifications, and registration activities as required; + ... and Preventive Actions (CAPA) to address nonconformances, trends, and regulatory issues by managing CAPA systems and...trends, and regulatory issues by managing CAPA systems and driving continuous improvements; + Stay current with… more
- J&J Family of Companies (Raritan, NJ)
- …custody for medicinal products companies + Experience in Testing, IT Project Management, Systems Support , IT Compliance, or associated track is required + ... with Veeva RIM product suite + Knowledge of global regulatory affairs, regulations, computer systems validation requirements,...+ Maintain and advance a positive team culture and support an authentic, open, and broad environment that enhances… more
- American Express (New York, NY)
- …Plan, execute and oversee detailed transaction testing across various card products and systems to validate data feeding into regulatory reports. Design and ... As part of Team Amex, you'll experience this powerful backing with comprehensive support for your holistic well-being and many opportunities to learn new skills,… more
- Medtronic (Los Angeles, CA)
- …Team with business unit Regulatory Affairs Specialists (RAS) to provide regulatory support for new product introduction (NPI) and marketed products under ... negotiate submission issues with agency personnel. + Reviews protocols and reports to support regulatory submissions. + Provide support to currently marketed… more
- Lilly (Indianapolis, IN)
- …to ensure + Compliance with all applicable regulations, internal policies and quality systems + High quality, timely and decisive regulatory advice to allow ... regulatory personnel supporting therapeutic area **Provide effective leadership and regulatory expertise to US Business Unit** + Support implementation of… more
- Kelly Services (Winston Salem, NC)
- …+ Compile and analyze technical data from QA, QC, and Manufacturing teams to support regulatory filings. + Ensure that all documentation aligns with ... Summary:** An advanced therapy biotech organization is seeking a **Manager, Regulatory CMC (Contractor)** to provide specialized support for Chemistry,… more