- Eisai, Inc (Nutley, NJ)
- …industry preferred.Skills:Eisai Salary Transparency Language:The base salary range for the Executive Director , Global Regulatory Affairs - Neurology ... want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide...Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Strategy : Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and updates within internal ... Point of Contact (PoC) for gathering country/region specific CDx RA requirements from local RA team members...Policy and Intelligence : Keep abreast of the changing global regulatory environment for devices and share/educate… more
- Pall (Miami, FL)
- …and innovation.Learn about the Danaher Business System which makes everything possible. Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets ... turn ideas into impact - innovating at the speed of life.As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on… more
- Eisai, Inc. (Nutley, NJ)
- …preferred. Skills: Eisai Salary Transparency Language: The base salary range for the Executive Director , Global Regulatory Affairs - Neurology is from ... want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide...Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under… more
- Merck & Co. (Rahway, NJ)
- …Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement ... Training Programs, FDA Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, … more
- Merck & Co. (Upper Gwynedd, PA)
- …and project regulatory strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting documentation ... regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the… more
- 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 ... support of global submissions and this position serves as the RA CMC representative supporting company initiatives (liaison with PhRMA, USP, ICH, due diligence,… more
- Genmab (NJ)
- …various regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. ... like a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible… more
- Insmed Incorporated (San Diego, CA)
- …also key duties. Collaboration with R&D, Process Development, Quality Control, and Regulatory Affairs is essential, as is facilitating technology transfers and ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... pull you in? Are you ready to experiment with us? The Position The Associate Director of Nephrology Key Opinion Leader Marketing will be a pivotal driver in shaping… more
- Twist BioScience (South San Francisco, CA)
- …and infrastructure teams, Manufacturing Operations, Quality Assurance, Process Development, and Regulatory Affairs teams to define MES requirements, design ... regulatory concepts.Ability to travel as required to support global biomanufacturing sites.Preferred QualificationsExperience with specific biopharmaceutical manufacturing processes… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …other functional teams in NNI (including MAPA), including marketing, medical, R&D, regulatory affairs , finance, NNGlobal, and other relevant entities to develop ... you ready to experiment with us? The Position The Director Channel Strategy & Planning will play a critical...Leadership Decision Support o Provide one unified NNI and global voice and point of voice to leadership to… more
- Acadia Pharmaceuticals Inc. (Princeton, NJ)
- …office three days per week on average. Position Summary The Director of Regulatory Affairs ( RA ) Labeling will lead the development of a cross-functional ... (eg, PharmD) preferred. Targeting 10 years of progressively responsible Regulatory Affairs experience and 8 years' experience in global labeling. This… more
- Abbott (San Diego, CA)
- … RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and US Regulatory Affairs . We're empowering smarter medical and ... female executives, and scientists. The Opportunity This position, Associate Director Regulatory Affairs , works...and recommend future strategies and actions. Develop and update global regulatory strategies based on regulatory… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …aspirations. Join Kite and help create more tomorrows. Job Description The Senior Director , Regulatory Affairs , Advertising and Promotion is responsible for ... developing and executing a regulatory strategy that enables the global business...Santa Monica, CA, and will report to an Executive Director in Regulatory Affairs . Responsibilities:… more
- Fate Therapeutics, Inc. (San Diego, CA)
- Fate Therapeutics is looking for an Executive Director or Senior Director in Regulatory Affairs to oversee and direct the strategic planning and ... located at our corporate headquarters in San Diego, CA. Responsibilities Lead the Regulatory Affairs team in effectively working with internal and external… more
- DermBiont (Emeryville, CA)
- …employees to do their best work. Overview: We are seeking a highly motivated Regulatory Affairs and Quality Assurance ( RA / QA) experienced professional to ... the regulatory strategy and to submit electronic regulatory filings. The RA / QA person will...of regulatory submissions for assigned programs to global regulatory authorities (FDA, EMA, etc.). Support… more
- BioSpace (Tarrytown, NY)
- …stakeholders, typically carrying out the responsibilities with minimal guidance from the Regulatory Affairs , Advertising and Promotion Director . The Senior ... a typical day might include: Management of US and Global (if applicable) regulatory activities associated with...advertising and promotion perspective with minimal guidance from the Regulatory Affairs , Advertising & Promotion Director… more
- System One Holdings, LLC (Tarrytown, NY)
- …report teams. Collaboration with Signal Management , Medical Safety , Clinical , Regulatory Affairs , and Biostatistics groups. Experience in matrix team ... Job Title : Temp - Associate Director , Aggregate Reporting, GPS Type : Contract Compensation...Safety (GPS) and with functional areas (Epidemiology, Clinical Development, Regulatory Affairs , Statistics, etc.) contributing to aggregate… more
- Revolution Medicines (Redwood City, CA)
- …authorities, ensuring accuracy, timely completion, and submission in compliance with global regulatory requirements and following best practices. Collaborate and ... related to PV aggregate reporting by ensuring processes and training reflect global regulatory requirements as applicable. Act as subject matter expert… more
