- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... and serves as ad hoc member to the Global Project Team for late stage projects. This position manages...content templates and leads technical team in preparation of submission documents; authors regulatory documents where necessary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the construction of clinical development plans, clinical protocols, and in submission of certain regulatory documents. Responsibilities:Develop and implement a ... and Japan, for a tight alignment with the Global Project Team. In addition, he or she will interact...of clinical development plans, clinical protocols, and in the submission of certain regulatory documents from the… more
- Merck & Co. (Rahway, NJ)
- …experts and regulatory colleagues in authoring of relevant regulatory submission analytical sections where needed.Required Qualifications:Education & ... Research and Development (ARD)-at our company's Research Laboratories is seeking a senior scientist to work onsite with extensive experience in validation &… more
- Merck & Co. (North Wales, PA)
- …software development life cycle (SDLC)US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Insmed Incorporated (San Diego, CA)
- …and procedures suitable for inclusion in pre-IND, IND, or equivalent regulatory submission ;Must be familiar with BSL-II lab safety requirements;Participate ... including interpretation of results and reporting that stands up to regulatory inspection.Demonstrate expert knowledge of scale-up principles with respect to viral… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for ... supporting the overall CMC strategies within projects, and manage project teams. The project teams will be...and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group ... review of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project life cycle is optimized across multiple programs. The CS group lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... protocol profiles, and sections of submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical… more
- American Honda Motor Co Inc (Torrance, CA)
- …contracts and business obligations.Focusing on financial accuracy as well as regulatory compliance supporting operations and providing new value to the Customer, ... the Dealer, and AHM, the Senior Analyst strategizes, plans, executes and reports all aspects...act as the leader to consolidate and validate for submission to executive management.Collaborate between auto operations and AHM… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Clinical Trial Application (CTA) submission deliverables + Manage CTA regulatory submission /document transfers between Regeneron and CROs. This can include ... Research Organizations (CROs), as well as corporate and collaborative partners, Regulatory Liaisons, vendor management and other cross-functional team members. **In… more
- Gilead Sciences, Inc. (Foster City, CA)
- …worldwide, with headquarters in Foster City, California. **About the Role:** The Senior Director, CMC Regulatory Affairs for Biologics is responsible for ... that is integrated into Pharmaceutical Development & Manufacturing (PDM) Project teams. The role will report directly to Head...operations. + Lead the execution of these global CMC regulatory plans, including overseeing the submission and… more
- Publicis Groupe (New York, NY)
- …with the stability and experience of a global leader. **Job Description** The Senior Manager, Regulatory Promotional Operations, is a subject matter expert ... to ensure a seamless MLR review process from start to finish. The Senior Manager provides expert guidance on submission timelines and resource requirements,… more
- Publicis Groupe (New York, NY)
- …of a global leader. **Job Description** The Senior Associate, Regulatory Promotional Operations is a project -level lead responsible for independently ... MLR process, facilitating effective communication among cross-functional team members regarding project statuses, advising on submission timelines, and following… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …and responses to regulatory agency requests: + develops and tracks submission timelines with RA Project Operations + actively participates in product ... evidence, and creating hope for all facing illness. The Senior Director, Regulatory Affairs - Clinical (Neuroderm),...and vendors); participates as a key member of Global Regulatory Project Teams; and represents Regulatory… more
- Medtronic (Minneapolis, MN)
- … department and other business functions. This position reports to the Senior Regulatory Affairs Manager. **Role And** **Responsibilities:** + Develop and ... MN but a remote worksite may be considered. The ** Senior ** **Principal Regulatory Affairs** will play a...and requirements for global commercialization. + Develop options of regulatory strategies, risks mitigation, issues and submission … more
- BD (Becton, Dickinson and Company) (Covington, GA)
- **Job Description Summary** Senior Regulatory Affairs Specialist - hybrid - Covington, Georgia Urology and Critical Care (UCC) is an established and trusted ... drainage process in the Acute Care Hospital setting. The Senior Regulatory Affairs Specialist is responsible for... support through the product life cycle on product project teams (eg, developing regulatory strategies, change… more
- Abbott (Alameda, CA)
- …their glucose levels with our new sensing technology. **The Opportunity** This ** Senior International Regulatory Operations Specialist** will work on-site at our ... glucose levels with our new sensing technology. As an individual contributor, the Senior Specialist will provide support for the regulatory department to ensure… more
- Stryker (Redmond, WA)
- …jurisdiction + Determine requirements (local, national, international) and options for regulatory submission , approval pathways, and compliance activities + ... regulatory authorities throughout the development and review process of a regulatory submission through appropriate communication tools + Evaluate proposed… more
- Abbott (Santa Clara, CA)
- …imaging catheters and software, vessel closure devices and peripheral stents. This ** Regulatory Affairs Senior Manager** position is an onsite opportunity ... changes + Support pre and post approval clinical strategy and submission activities + Anticipate regulatory obstacles and emerging issues throughout… more
- West Pharmaceutical Services (Exton, PA)
- …a healthier environment and planet through our sustainability efforts. **Job Summary:** This Senior Specialist, Regulatory Project Management (RPM) role is ... Sr. Specialist, Regulatory Project Mgmt Requisition ID: 66496...(RA) team's priorities. + Manage the preparation, review, and submission of complex global regulatory filings, information… more
