- Catalent (Manassas, VA)
- Associate Director , Regulatory Affairs Position Summary: Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical ... safety of every patient, consumer and Catalent employee. The primary duty of the Associate Director , Regulatory Affairs is to support regulatory strategy… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Director , Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their ... Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Develops… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain ... SOPs and Federal and State regulations, including compilation and submission of any required documents to regulatory ...positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and… 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)
- …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)
- …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: Apr 20, 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
- System One (Deland, FL)
- Position: CONTRACTOR -- Director , US Regulatory Affairs & Global Development Projects (GDP) Location: Remote (East or Central Time Zone) / Prefers local ... 80/hr - 95/hr Purpose and Scope of Position The Director , US Regulatory Affairs &...and launches. This role oversees the preparation, review, and submission of regulatory filings to the FDA,… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director , Regulatory Affairs II Date: Apr 20, 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
- Catalent Pharma Solutions (Hillside, NJ)
- **Associate Director , Regulatory Affairs ** **Position Summary:** Catalent is a global, high-growth, public company, and a leading partner for the ... and Catalent employee. The primary duty of the **Associate Director , Regulatory Affairs ** is to...experience and sound knowledge of GMP regulations and multi-national regulatory submission requirements + Must demonstrate organizational… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director , Regulatory Affairs CMC , Innovative Medicine (Hybrid) Date: Apr 26, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: ... to make a difference with. **The opportunity** The Senior Director , Regulatory Affairs CMC is...the development teams. + Develop and communicate effective CMC regulatory strategies for development and post marketing submission… 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
- University of Colorado (Aurora, CO)
- Regulatory Affairs Program Director - 32624 University Staff **Description** **University of Colorado Anschutz Medical Campus** **Department: Gates ... Institute** **Job Title: Regulatory Affairs Program Director ** **Position...+ Leading cross-functional collaboration to ensure the preparation and submission of regulatory documentation are of the… 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
- Medtronic (Boston, MA)
- …you need to own your future success. Together, we can transform healthcare. The Senior Director of Regulatory Affairs will lead the Regulatory team ... be required. This role reports to the Vice President, Regulatory Affairs for the Surgical Operating Unit...regulators, other regulatory authorities and consultants regarding regulatory submission strategy and approval reviews +… more
