Collaborate with key stakeholders and cross-functional partners (Development, Safety, Regulatory Affairs, HEOR, Medical Affairs, Precision/Molecular Medicine, and Genetics Research Center) to propose and execute on epidemiology and RWE studies that support key asset strategy needs.

In collaboration with the Clinical Affairs Lead and Medical/Scientific Lead, prepares strategy decisions, presents, and discusses data at relevant team, governance, external consultants, KOL and potentially regulatory meetings.

Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams, and Operations brand teams for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions.

The position of Scientific Affairs Director is within our Toxicology business unit. Data review for immunoassay screening and mass spectrometry results. The position of Scientific Affairs Director is within our Toxicology business unit.

Manage the bioanalytical assay transfer/validation, quality and conduct at external bioanalytical vendors and ensuring regulatory compliance. + Working knowledge of bioanalytical method validation and sample analysis regulatory guidelines in all regions (ICH, FDA, EMA, PMDA.

Maintain a safe work environment and wear appropriate personal protective equipmentRequirements: Bachelor's degree in Biology, Chemistry, Clinical Laboratory Science, Medical Technology or meet local regulatory (CLIA & State) requirements.

This role will provide CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, and Regulatory colleagues to ensure a robust CMC regulatory strategy is developed and implemented to have on time submissions with the highest quality to meet global health authority expectations.

You will lead a program focused on managing third party providers, import duty expense, customs classification, maintaining good standing and participation in programs with U.S. Customs and Border Protection, ensuring all U.S. and Canadian import compliance regulatory requirements are met and fostering a culture of integrity and ethical conduct throughout the organization.

This includes the management and preparation of various critical regulatory documents such as: product Safety Data Sheets, product labels, product attestation documents and certifications. Required Knowledge: Regulatory, Scientific/Technical, QA, Business acumen.

Certification in Control Self-Assessment, Certified Internal Auditor (CIA), Certified Public Accountant (CPA), Certified Regulatory Compliance Manager (CRCM) + Provides education and monitors employees on the requirements of company policies and standards related to risk and control ownership, the development and execution of new products and services, regulatory change management, issue resolution, and control testing.

Collaborate with Regulatory Affairs and Pharmacovigilance in the development of product labeling and periodic safety reports, as applicable. Purpose and Scope:The Medical Lead, Oncology, MUS (Medical Affairs-United States), is accountable for the development and execution of medical and scientific strategies for one or more products within the Therapeutic Area (TA.

Understanding of regulatory bodies and statutes that cover value-based care. The Medical Director, Patient Safety and Risk Management will also ensure compliance with regulatory requirements and promote a culture of safety and continuous improvement.

This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). We assist companies and non-profit organizations in delivering benefits to their employees.

Under the general direction from the Corporate EHS Manager develop and implement EHS plans, training requirements and ensure compliance with OSHA and EPA regulatory requirements and SOPI’s. Understand the relationship with FM Global and knowledge on risk evaluation, fire protection and emergency response.

Supply Chain Operations : Extensive techno-functional experience in supply chain operations including Demand Planning and Forecasting, Supply Planning and Inventory Optimization, Sales and Operations Planning, Procurement and Supplier Management, Network Optimization, Inbound Logistics and Transportation, Analytics and Reporting, Traceability, Recall and Regulatory Compliance Management.