- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with respect to impact development programs. Additionally, this position interacts with Regulatory Affairs (RA) team members, cross-functional team members, FDA ... Experience in the pharmaceutical industry7 or More Years with direct regulatory affairs experienceManagerial experience preferredExperience with ex-US … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …years of experience within Regulatory AffairsKnowledge of IND, NDA/BLA submission experienceExperience with regulatory submission strategy globally will ... and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …speed to patients.ResponsibilitiesCDx development: Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission ... rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …DSI's mission to fund independent or partnered initiatives managed by Medical Affairs , triaging any open issues and bringing forward proposed recommendations to the ... for collecting, discussing, and evaluating all information throughout the submission , implementation, and reconciliation of such requests. Accurately and efficiently… more
- Merck & Co. (Rockville, MD)
- …Research and Development Division's colleagues, regulatory liaison staff, and local regulatory affairs staff for submission of product applications and ... with the company's Research Laboratories divisions and most directly with Global Regulatory Affairs and Clinical Safety (GRACS) to define and implement… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …More Years Pharmaceutical industry and Regulatory operations required.4 or More Years regulatory affairs including filing NDA and sNDA. BLA filing to FDA ... areas centered around rare diseases and immune disorders.Summary The Director , Head of Global Dossier Planning, Regulatory ...a seamless flow of documents in order to meet submission timelines. The Director will develop the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etc. Qualifications: Successful candidates will be ... all statistical programming activity related to study, project and submission . Manage CRO to ensure high quality compound and...and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery ... for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... submission documents; Point of contact for interactions with regulatory -agency clinical reviewing divisions on clinical matters; Supports marketing in developing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etc. Qualifications: Successful candidates will be ... all statistical programming activity related to study, project and submission . Manage CRO to ensure high quality compound and...and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... submission documents; Point of contact for interactions with regulatory -agency clinical reviewing divisions on clinical matters; Supports marketing in developing… more
- Teva Pharmaceuticals (West Chester, PA)
- Director Regulatory Affairs - Submission Management - West Chester, PA Date: May 19, 2024 Location: West Chester, United States, Pennsylvania, 19380 ... Medicine Dossier Project Manager, a key member of Global Regulatory Affairs , will be responsible to develop...This role requires utilization of in-depth knowledge of global regulatory submission requirements, processes and procedures, eCTD… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs , is responsible for the development ... pertain primarily to marketed products in US and Canada. In addition, the Senior Director , Commercial Regulatory Affairs , in collaboration with Head, … more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director , Regulatory Affairs II Date: May 19, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva Pharmaceuticals Job Id: ... to make a difference with. **The opportunity** The Senior Director , Regulatory Affairs II will...how systems are integrated to support day to day regulatory and submission publishing business processes with… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC (Biologic Products) Date: May 15, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC...the development teams. ⦁ Develop and communicate effective CMC regulatory strategies for development and post marketing submission… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. **Sr Director , CMC Regulatory Affairs -Small Molecules** **KEY RESPONSIBILITIES** ... The Sr Director , CMC Regulatory Affairs for Small Molecules is responsible...of commercialization. + Leads the execution of global CMC regulatory plans, including overseeing the submission preparation… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Senior Director - Global Regulatory Leader - ... this. Let's change the world. Amgen is seeking a Regulatory Affairs Senior Director supporting...+ Ensure consistency of evidence-based global product communication (eg, regulatory submission documents) + Monitor and assess… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- **Job Description Summary** As Associate Director , Regulatory Affairs , you will be responsible for managing a team that develops and executes the strategy ... and timelines for submission of various regulatory licensing activities for...and regulation or guidance changes to Corporate Quality and Regulatory Affairs . International Regulatory … more
- Taiho Oncology (Pleasanton, CA)
- Sr. Director , Regulatory Affairs Strategy Pleasanton, CA, USA Req #356 Friday, March 29, 2024 Looking for a chance to make a meaningful difference in the ... and Asia. For assigned projects and products, the Senior Director , Regulatory Affairs Strategy is... subgroups, and regions + Author, review, and approve regulatory submission documents, including regulatory … more
- Teva Pharmaceuticals (West Chester, PA)
- Director , Regulatory Affairs , Strategy - Innovative Medicine (West Chester, PA or Remote) Date: Apr 29, 2024 Location: West Chester, United States, ... people to make a difference with. **The opportunity** The Director , Global Regulatory Affairs , is...regulatory knowledge of IND and NDA/BLA content and submission experience. Working within Teva Innovative Medicines, this role… more
