- System One Holdings, LLC (Florham Park, NJ)
- …information management tasks including file transfer, storing, tracking, and archiving of regulatory submissions . Maintain knowledge of local regulatory ... DMF). Ensure consistency across regulatory submission documents following the regulatory style guide (ie formatting, reviewing, and submissions ). Provide… more
- Katalyst HealthCares and Life Sciences (Newark, NJ)
- …such as Commercial. Key contributor responsible for the preparation and review of regulatory submissions consistent within global regulatory requirements and ... Responsibilities: The Regulatory Affairs Manager is responsible for the development...is responsible for the development and execution of global regulatory strategy and tactical planning for assigned microbiology on… more
- VCLS (Somerville, NJ)
- …agencies worldwide. If you thrive in a detail-oriented environment and have experience with regulatory submissions , we want to hear from you! What You'll Do: * ... meet the highest standards. * Quality Control: Perform thorough QC checks on submissions , ensuring adherence to regulatory guidelines and internal processes. *… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …multiple therapeutic areas and is capable of leading DM activities to support regulatory submissions and inspections. Finally, this position has advanced skills ... this position possesses advanced knowledge of clinical operations and relevant regulatory requirements. This position has advanced experience working on Phase I-IV… more
- IQVIA, Inc. (Parsippany, NJ)
- …issues as appropriate. *Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form ... and close-out visits) in accordance with contracted scope of work and regulatory requirements, ie, Good Clinical Practice (GCP) and International Conference on… more
- Bristol-Myers Squibb Company (Princeton, NJ)
- …questions Participates in post-hoc biomarker analysis and publication efforts Supports regulatory submissions and regulatory interactions as needed ... activities for the pipeline and supports late stage portfolio for regulatory , translational development and life cycle management. Translational Development drives… more
- Bristol-Myers Squibb Company (Princeton, NJ)
- …after clinical proof-of-concept studies, including but not limited to regulatory submissions and life-cycle management. Translational disease strategies ... PC space Manages relationships with key internal stakeholders including Regulatory , Clinical, Commercial, Medical Affairs & Communications and external collaborators… more
- The Fountain Group (Basking Ridge, NJ)
- …post-marketing surveillance, signal detection and management, important safety topics, and regulatory submissions . This individual will ensure proactive safety ... the Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other departments to… more
- Bristol-Myers Squibb Company (Summit, NJ)
- …assessments. Author or review CMC summaries of validation for worldwide regulatory submissions for initialization and life-cycle changes. Design qualification ... the stated areas of scope in this function. Experience leading regulatory inspections regarding validation and extensive knowledge of regulations, current industry… more
- Katalyst HealthCares and Life Sciences (Trenton, NJ)
- Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing ... packages, IND/CTA, NDA, and MAA regulatory filings. Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and… more
