- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for producing ... and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA submissions, working… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve as ... difference? The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines. You… more
- The George Washington University (Washington, DC)
- I. JOB OVERVIEW Job Description Summary: The Director , Regulatory Oversight position reports to the Associate Provost Research Integrity and Compliance (AP-RIC) ... oversight of the research radiation and laser safety programs. The Director , Regulatory Oversight works closely with Office of Research Integrity and Compliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support...of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's ... regulatory group in internal and external development project meetings....guidance to peers and cross-functional team members regarding strategic regulatory issues. Develops timeline and strategic input with feedback… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, and other ... regions. This position ensures alignment of regulatory strategies within the department and adherence to therapeutic area direction and corporate objectives. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support...of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, annotated labeling, medication guides, EU… more
- Merck & Co. (Rahway, NJ)
- …Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This includes ... performance against metric targets.Complete Impact assessment on new or changed external regulatory policies as it pertains to the processes that they own.Lead… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director /Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the ... and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional… more
- ITS Con Global (Fort Worth, TX)
- OverviewThe Director , Safety and Regulatory Compliance is responsible for the successful development, implementation, maintenance, communication and training of ... OSHA, FRA, and other state, local or industry specific regulations. The Director , Safety and Regulatory Compliance will manage and develop a core safety team and… more
- Signature HealthCARE (Owensboro, KY)
- …HealthCARE! How you Will make a difference Ensure that a company-wide regulatory compliance program is ongoing in accordance with company policies, standards of ... clinical care that meet state/federal regulations to promote excellence in care and quality of life for each residentProvide oversight and guidance to staff in all facilities which includes teaching, training, and application of compliance skills necessary to… more
- Signature HealthCARE (Nashville, TN)
- …HealthCARE! How you Will make a difference Ensure that a company-wide regulatory compliance program is ongoing in accordance with company policies, standards of ... clinical care that meet state/federal regulations to promote excellence in care and quality of life for each resident. Provide oversight and guidance to staff in all facilities which includes teaching, training, and application of compliance skills necessary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring CMC… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro Delaware seeks to add an Attending Veterinarian in the role of Associate ... Director .This position will have overall responsibility for oversight and...other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory… more
- Tris Pharma (Monmouth Junction, NJ)
- …Junction, New Jersey, Tris has an immediate opening for a full-time permanent Director /Senior Director , Clinical Quality Assurance. This is a hybrid position. ... with experience.SUMMARY:Reporting to the Chief Quality Officer the Senior Director of Clinical Quality Assurance provides strategic leadership and direction… more
- Merck & Co. (Rahway, NJ)
- …Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Director . QP2-IO team is part of the Global Clinical Development organization and ... of the strategic elements of drug development. As a subject matter expert, the Director within the QP2-IO Group will work closely with teams of highly collaborative,… more
- Merck & Co. (Durham, NC)
- Job Description- The Associate Director of Quality Systems provides leadership, focus, and governance to the Hilleman site in the following Quality Systems: ... and aligned with strategic direction defined by the global business model and regulatory agencies.- The role will require working with both global and local teams.-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
