- Usaa (Tampa, FL)
- …broker markets Comprehensive knowledge of commercial Business classification and multi-state regulatory compliance , ensuring quality submissions and appropriate ... markets Supports achievement of business objectives including compliance and regulatory action, revenue/growth targets, call center performance and product… more
- VSolvit LLC (Huntsville, AL)
- POSITION IS HYBRID IN HUNTSVILLE, AL Job Summary The Senior Contracts Manager is responsible for strategic oversight and operational managementof all government ... internal policies Mitigate Risk Proactively:Identify, quantify, and manage contractual and regulatory risks at every stage of the contract lifecycle Enhance… more
- Reed Smith LLP (New York, NY)
- …structure make us the go-to partner for complex disputes, transactions and regulatory matters. Our team of 3,000 people (including more than 1,600 lawyers) ... markets. The primary responsibilities will encompass partnering with the Senior Manager of Business Development through the development of pitch decks, drafting… more
- Boehringer Ingelheim (Ridgefield, CT)
- …the planning and execution of regulatory submissions coordinated by the Regulatory Project Manager . + Support submission rollout for Rest of World (RoW) ... among team members, encourage cross-functional coordination and coordinate with the (senior) regulatory project manager to achieve regulatory milestones &… more
- Dana-Farber Cancer Institute (Boston, MA)
- …group's Clinical Research Manager in their resolution + Manage the regulatory documentation submissions that may include the preparation and submission of ... to the CTIP Associate Director for Reg unit, the Regulatory Operations Manager (ROM) will oversee the... Regulatory coordinators) is responsible for closely managing regulatory submissions and communication process, following a… more
- AbbVie (Irvine, CA)
- …enable first pass approvals. Develops and manages content strategy for regulatory submissions , including INDs/CTAs and amendments, new marketing applications ... + Prepares device regulatory product strategies. Prepares and manages regulatory submissions , including new applications and amendments, renewals annual… more
- Globus Medical, Inc. (Audubon, PA)
- …and filing 510(k), IDE, PMA submissions , FDA reports, all international regulatory submissions and registrations, responds to questions, and achieves timely ... can resume their lives as quickly as possible. **Position Summary** **:** The Manager , Regulatory Affairs, is responsible for preparing, filing and gaining… more
- Dentsply Sirona (Milford, DE)
- …for medical devices and other regulated products globally. + Leads and manages regulatory submissions , including 510(k) submissions , and technical files for ... preferably in the medical device industry. + Experience with leading regulatory submissions and managing regulatory projects. + In-depth knowledge of… more
- Taiho Oncology (Princeton, NJ)
- …and support the preparation, review, and submission of all components of regulatory submissions as assigned, including INDs and amendments, CTAs, marketing ... annual reports, safety reports, etc. + Support planning and executing regulatory submissions requiring cross-functional collaboration and alignment. + Prepare,… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC ... planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with… more
- Ascendis Pharma (Palo Alto, CA)
- …of Global Regulatory Affairs, providing project management leadership to key global regulatory submissions across the Ascendis pipeline. As a part of the ... for employees to grow and develop their skills. The Regulatory Project Manager will be an integral...in the end-to-end planning, coordination, and execution of assigned Regulatory submissions project deliverables. + Monitor submission… more
- HSBC (Buffalo, NY)
- …and other BAU activities. They are responsible for reviewing and approving regulatory submissions including ad hoc requests, responses to examinations, and ... US Technology Regulatory and Controls Manager Brand: HSBC...technology teams, RLO, 3LOD, 2LOD and CCO to ensure regulatory submissions are accurate and consistent across… more
- Stryker (Mahwah, NJ)
- …for new product launches, ensuring alignment with business objectives. + Manage regulatory submissions for market access, including 510(k), PMA, and ... **Senior Manager , Regulatory Affairs - Joint Replacement...to maintain compliance. + Ensure accuracy and completeness of submissions , labeling, and marketing materials to meet regulatory… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …CMC requirements. + Plan, prepare, and review CMC sections of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory ... global submissions , and post-marketing lifecycle management as the CMC Regulatory lead. + Regulatory experience in handling-controlled substance applications… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …objectives for the assigned products or projects. You will typically lead the Regulatory Submissions Teams associated with assigned products or projects and ... plans. + Leads the preparation, compilation, and timely filing of regulatory submissions , which require cross-functional interactions for commercial or… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …holders/ distributors / regulatory authorities the information required and prepare regulatory submissions to be used worldwide for all marketed products. + ... all disciplines to assure appropriate testing and documentation are generated for regulatory submissions and routine import documentation. Prepare personnel from… more
- Reckitt (Evansville, IN)
- Regulatory Manager City: Evansville **We are Reckitt** Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why ... allow you to grow in our great organisation. **About the role** This pivotal Regulatory Manager role offers you the opportunity to champion collaboration across… more
- Astellas Pharma (Northbrook, IL)
- … Excellence** + Leads the development, implementation and successful application of robust regulatory strategy input to assigned areas for submissions such as ... variations) across assigned development projects and/or commercial products. Assures submissions reflect the best-in-class application of regulatory standards… more
- Abbott (Alameda, CA)
- …cross-functional teams as the regulatory SME, provide support for compiling regulatory submissions , and ensuring data is effectively presented for the ... for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work on-site at… more
- J&J Family of Companies (Irvine, CA)
- …III Medical Devices, Regulatory Approvals, Regulatory Processes, Regulatory Requirements, Regulatory Submissions **Preferred Skills:** Analytical ... We are searching for the best talent for a ** Manager , Regulatory Affairs** . _The preferred location...with Advanced Degree_ ). + Class III Medical Device Submissions and Assessment Experience **required** . + Experience with… more
