- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director , Device Quality & Regulatory will play a pivotal leadership role within the organization, overseeing the quality ... and implement continuous improvement strategies for device quality and regulatory processes.Monitor and ensure compliance with global regulations and … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …make a difference? The Position Reporting to the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for ... execute and deliver clinical studies/programs on time with a focus on budget, compliance and quality . Leads strong and effective communication to global and… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... compliance mindset.Essential Knowledge, Duties & Responsibilities for the Director Include:Biopharmaceutics expertise supporting delivery of small molecule, peptides… more
- Tris Pharma (Monmouth Junction, NJ)
- …Administration (FDA) guidance and provides technical guidance within and outside R&D for regulatory and quality matters.The Associate Director / Director , ... builds in-house analytical capabilities, when needed. The incumbent ensures timeline, quality and compliance with applicable Standard Operating Procedures… more
- Merck & Co. (Rahway, NJ)
- …and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing division.This challenging position ... chemical and biochemical processes, parenteral, oral, and specialty dosage formulations.- The director should be well engaged with regulatory and industry trends… more
- Aequor (Devers, TX)
- …with excellent relationship management and analytical skills. MES , Automation, IT Quality & Compliance , Enterprise System Integrations, IT infrastructure and IT ... Sr. Director , IT Cell Therapy Devens Manufacturing Site (DVN...process automation systems, MES, LIMS, application integrations, local manufacturing, quality control and quality management site IT… more
- Merck & Co. (Millsboro, DE)
- …DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/ ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...species including chickens, turkeys, dogs, cats, rabbits, and rodents.Assure compliance with all federal and state regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes ... tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes… more
- Eisai, Inc (Nutley, NJ)
- …the strategic and execution perspectives for Eisai. Reporting directly to the Executive Director , IT Security, Compliance , & Architecture, s/he is the Global IT ... assesses and provides objective risk assessments and guidance regarding Eisai's compliance with regulatory , organizational, and commercial requirements that… more
