- 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
- 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
- Merck & Co. (North Wales, PA)
- Job DescriptionOur Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, efficient, and ... compliant drug/diagnostic regulatory strategies and approaches across geographies.Under direction of the Executive Director , Companion Diagnostics/In Vitro… 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. (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
- 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
- Lennar Homes (Alpharetta, GA)
- …wetlands, modules. Regularly interact with the Regional Environmental Manager (REM), Director of Construction, regulatory agencies, and division associates.A ... Storm Water Pollution Prevention Plans and Best Management Practices.Interact with the Director of Construction, Director of Land Development and Regional… more
- Lennar Mortgage (San Antonio, TX)
- …will be required to regularly interact with the Regional Environmental Manager (REM), Director of Construction, regulatory agencies, and division associates. * A ... Storm Water Pollution Prevention Plans and Best Management Practices.Interact with the Director of Construction, Director of Land Development and Regional… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (Washington, DC)
- Job DescriptionPosition Description: Director , Policy Development The Director , Policy Development serves as the leading expert on above-product public policy ... and geo-political changes that will impact our global business.The Director independently and proactively identifies risks and opportunities, conducts analysis… more
- Merck & Co. (Rahway, NJ)
- …Point, PA / Rahway, NJ is seeking a curious and collaborative Director to support our rapidly expanding cardiology respiratory, metabolism and ophthalmology ... pipeline.As a Director , you will serve as an expert QP2 representative...vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug… more
- Merck & Co. (Washington, DC)
- Job DescriptionPosition Description: Associate Director , Policy Advocacy The Associate Director , Policy Advocacy serves as the senior expert in the Global Public ... policy change in support of the company's business objectives. The Associate Director will proactively research and stay abreast of new strategies and tactics… more
