- CSL Behring (King Of Prussia, PA)
- …successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling ... in the biotech or pharmaceutical industry, with exposure to regulatory activities/ submissions and 3 years working on... and 3 years working on developmental products. Previous regulatory affairs experience is preferred. + Experience… more
- J&J Family of Companies (Titusville, NJ)
- …Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Product Submissions and Registration **Job Category:** Professional **All Job ... responsible for the operational management and delivery of global clinical trial regulatory submissions . + Create and handle dossier plans/submission packages in… more
- Globus Medical, Inc. (Audubon, PA)
- …patients can resume their lives as quickly as possible. **Position Summary** **:** The Manager , Regulatory Affairs , is responsible for preparing, filing and ... and filing 510(k), IDE, PMA submissions , FDA reports, all international regulatory submissions and registrations, responds to questions, and achieves timely … more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC ... and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- J&J Family of Companies (Titusville, NJ)
- …Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Product Submissions and Registration **Job Category:** People Leader **All ... way. Learn more at https://www.jnj.com/innovative-medicine We are seeking **Senior Manager , RA Submissions ** to be located Raritan,...+ Bachelor's Degree or higher in Life Sciences, Pharmacy, Regulatory Affairs , or a related field. +… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting and gaining clearance ... a plus + Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry,...and registration of products + Demonstrated knowledge of US regulatory submissions ; Pre-Sub, and 510(k); working knowledge… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance ... Obtaining and reviewing clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as...device industry or equivalent, preferably within orthopedic medical devices; Regulatory Affairs experience is a plus. +… more
- University of Pennsylvania (Philadelphia, PA)
- …to participate in the coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager , the Regulatory ... trials that offer cutting-edge oncology treatments. Contingent upon funding. The ACC OCCR Regulatory Affairs Office seeks a full-time Regulatory Affairs… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …product strategy and scientific messaging. + Collaborate cross-functionally with Medical Affairs , Regulatory , Legal, and Commercial teams to ensure consistency ... The Manager , Medical Core Content is a team-level operational...Veeva Vault, to manage content lifecycle and Medical Review submissions . + Track and report content usage and effectiveness,… more
- University of Pennsylvania (Philadelphia, PA)
- …review proposals for compliance with sponsor and University policies and ensure Regulatory Affairs requirements are satisfied and that Conflict of Interest ... and resources, and much more. Posted Job Title Grants Manager A/B Job Profile Title Grants Manager ... will be responsible for multiple monthly pre-award proposal submissions for various PIs. Tasks include managing proposal development,… more
- Eliassen Group (Trenton, NJ)
- …risk management, and communication across all stakeholders. * Coordinate with Regulatory Affairs to ensure documentation and submission readiness for ... **Project Manager , Med Device, R&D PMO, Design Changes** **Anywhere**...and industry regulatory standards. * Exposure to Regulatory submissions and Operations/manufacturing interfaces. * Background… more
- Sumitomo Pharma (Trenton, NJ)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is essential. ... software + Ability to evaluate and write case reports and prepare regulatory submissions + Analytical thinking and attention to detail + Communication skills for… more
- Globus Medical, Inc. (Audubon, PA)
- …technique guides, brochures and other marketing/sales support materials + Partnering with Regulatory Affairs in planning, coordination, writing, and execution of ... 510(k), IDE & PMA submissions and approvals + Collaborating with VP, Strategy & Corporate Development to ensure that Globus can attract and retain the best… more
- University of Pennsylvania (Philadelphia, PA)
- …specimens and manage study data and regulatory files per GCP.Work with Regulatory Affairs Specialist to prepare for audits, review regulatory binders, ... study team.CRC B: With the help of the project manager , manage/coordinate/organize the daily work of research assistants for...such as:Assist in development of study documents. Work with Regulatory Specialist for regulatory submissions .… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …accurate, evidence-based, and compliant with internal policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs , ... core scientific lexicon and messaging, ensuring its consistent application across all Medical Affairs materials through clear guidance to the Manager of Core… more
- University of Pennsylvania (Philadelphia, PA)
- …related activities delegated to research coordinator who provides study related support (eg, regulatory submissions and data entry). + May be responsible for ... activities delegated to research coordinators/assistants who provide study related support (eg, regulatory submissions and data entry). May be responsible for… more
- University of Pennsylvania (Philadelphia, PA)
- …complex Phase I, II, or III oncology clinical trials. + Assist the Regulatory Coordinator by preparing components of submissions (eg, institutional forms, ... Sponsor/CRO. This position will report directly to the Program Manager and work directly with PIs and clinical research...IRB stipulations, queries and concerns; remain aware of the regulatory statuses for assigned protocols. + Lead or contribute… more
- University of Pennsylvania (Philadelphia, PA)
- …materials for reports, meetings, presentations, and response to sponsors. 5) Regulatory submissions inclusive of modifications and continuing reviews. Hybrid ... materials for reports, meetings, presentations, and response to sponsors. 5) Regulatory submissions inclusive of modifications and continuing reviews. +… more
- University of Pennsylvania (Philadelphia, PA)
- … submissions to determine the appropriate level of review and triaging submissions to the scientific, statistical reviewer and/or regulatory reviewer as ... Title Coordinator C Job Description Summary Reporting directly to the CTSRMC Manager , the Clinical Trials Scientific Review and Monitoring (CTSRMC) Coordinator C is… more
- University of Pennsylvania (Philadelphia, PA)
- …and process all Institutional Review Board (IRB)through the IRB and other regulatory groups as appropriate including initial submissions , amendments, continuing ... and research related presentations. Works closely with the Principal Investigator, manager , and study team to identify problems and develop solutions. Implement… more
