- Formation Bio (New York, NY)
- …Understanding of FDA/ international regulations, ICH guidelines, and applicable US/ international regulatory processes related to document preparation and ... (IBs), clinical summaries and overviews, and clinical study reports (CSRs); regulatory documents (meeting and briefing packages, regulatory filings); and… more
- Eisai, Inc (NJ)
- …management concepts.Must have a detailed knowledge of domestic and international regulatory requirements (including ICH and GCP guidelines)Expertise ... TMF vision and transformation initiative and is compliant with ICH-GCP and regulatory requirements. This role also provides direction, leadership and training on the… more
- Repligen (Rancho Dominguez, CA)
- …the direct Supervisor of any problems.Comply with applicable FDA and international regulatory laws/standards and the Repligen Code of ... Conduct.QualificationsEducation and/or Work Experience Requirements: High School Diploma, GED, or equivalent required.2-3 years of fiber extrusion-related experience.Knowledge of 5S techniques and Lean Manufacturing Skills.Physical Requirements: Regularly… more
- Merck & Co. (North Wales, PA)
- …the Executive Director, RIIM , this role will be accountable to ensure a holistic Regulatory centric D ata M anagement ( R DM) capability and related data centric ... This role has broad accountabilities for the following: - Regulatory Data Management ( RDM) Strategy & Regulatory...Fa nd EMA PMS) - Represent the Company in international trade association committees and meeting groups associated with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory ... Process Excellence & Analytics function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and compliant… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards. ... while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role… more
- Merck & Co. (Rahway, NJ)
- …International Trade Law, Investigative Skills, IS Audit, Legal Regulatory Compliance, Metrics Analysis, Problem Solving, Process Improvements, Project Management, ... Job DescriptionReporting to the Customs & International Trade (CIT) Tariff Classification Associate Director, the Senior Specialist will work closely with our… more
- Repligen (Waltham, MA)
- …North America, EMEA, APAC, andLATAM.Skill & Competencies Deep knowledge of international payroll legislation, tax compliance, and regulatory environments. ... current and future compliance with all applicable local, regional, and international payrollregulations, tax laws, labor codes, and social security requirements.… more
- Merck & Co. (Rahway, NJ)
- …International Trade Law, Investigative Skills, IS Audit, Legal Regulatory Compliance, Metrics Analysis, Process Improvements, Project Management, Project ... Job DescriptionDescription Reporting to the Customs & International Trade (CIT) Valuation Associate Director, the Senior...Management Information Systems (PMIS), Project Risk Assessments, Regulatory Affairs Management, Regulatory Reporting, … more
- Tris Pharma (Monmouth Junction, NJ)
- …pain and addiction addressing unmet patient needs. We have more >150 US and International patents and market several branded ADHD products in the US We also license ... writing expertise and leadership in the preparation of clinical and regulatory documents. Collaborating closely with cross-functional teams to ensure accuracy and… more
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