- 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
- Sanofi (Morristown, NJ)
- Job Title: Director , Global Regulatory Affairs - Global Labeling Strategy Location : Morristown, NJ or Cambridge, MA (Hybrid) About the Job Are you ... families. Your skills could be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs - Global Labeling Strategy… 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
- Genmab A/S (Princeton, NJ)
- …a fit? Then we would love to have you join us! Genmab is looking for an Associate Director , Global Regulatory Affairs , Regulatory Strategy to be a ... part of our Global Regulatory Affairs organization. In this role, you...global regulatory lead to ensure optimal regulatory success. Represent US RA in the… 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
- Eli Lilly and Company (Indianapolis, IN)
- …them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use ... approval. Development of regulatory strategy and update strategy based upon global regulatory changes. Provide regulatory guidance to allow CMC teams to… 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
- Cytokinetics (South San Francisco, CA)
- … Director , Regulatory Affairs to join the Global Regulatory Affairs team. The Senior Director will be responsible for developing, implementing ... regulatory requirements and industry standards are met. The Senior Director , Regulatory Affairs will lead the Global Regulatory Team for an… more
- System One Holdings, LLC (Florham Park, NJ)
- Job Title: AD or Director , Regulatory Affairs Strategy Location: Florham Park, NJ (10 days onsite per month) Type: 12-month contract Must haves : Must be ... experience in IND/NDA development, not just life cycle management. Overview Support the Regulatory Affairs (Executive Director ) in developing and executing … more
- Cedent (Cambridge, MA)
- …years in Regulatory Affairs . Experience in key areas of regulatory affairs , including strategy development, global submissions, agency meetings, and ... programs. The role involves direct interaction with the FDA and global regulatory agencies, leading submissions, and providing regulatory guidance across… more
- Organon (Plymouth Meeting, PA)
- …efficient, agile manner. Provide Regulatory CMC and oversight in developing global Regulatory CMC strategies and executing submissions related to diverse ... Job Description The Position The Principal Scientist ( Director ) Regulatory CMC is responsible for...He/she must have a depth of experience in defining global regulatory CMC strategies, superb collaboration skills,… more
- Clinical Dynamix, Inc. (Watertown, MA)
- …Collaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs , Biostatistics, Translational Medicine and Program ... expanding for their high profile clinical development trials. The Director , Clinical Operations is a leadership role responsible for...and leading a team is a plus Expertise in global regulatory and compliance requirements for clinical… more
- Johnson and Johnson (Raynham, MA)
- …SUPPORT Work with cross-functional partners, including but not limited to R&D, Clinical Affairs , Regulatory Affairs , Health Economics & Market Access (HEMA) ... of America Job Description: Johnson and Johnson is currently seeking a Medical Director , Medical Affairs , Orthopedics (Spine) located in Raynham, MA. About… more
