A company is looking for a Sr. Manager, Regulatory Affairs III to provide strategic direction and operational support for CMC regulatory activities.
Key ResponsibilitiesPrepare and oversee complex regulatory CMC submissions for investigational and commercial productsCollaborate with cross-functional teams to develop CMC submission plans aligned with business objectivesLead interactions with FDA and other Health Authorities regarding CMC-related topicsRequired QualificationsExperience in Regulatory Affairs CMC or relevant industry experience with an advanced degreeExperience with Life Cycle ManagementDemonstrated track record of managing CMC Regulatory activities in a global matrix team environmentDeep understanding of global regulatory requirements and guidelines
Senior Manager Regulatory Affairs
Manager, Regulatory Affairs III to provide strategic direction and operational support for CMC regulatory activities. ...
Senior Advisor, Global Regulatory Affairs, CMC, Biotechnology
The regulatory scientist in Global Regulatory Affairs – CMC Biotechnology will leverage CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for marketing authorizations for the bioproduct portfolio. We are seeking Regulatory Scientist G...
Senior Manager Regulatory CMC
Chemistry; advanced degree is a plus6+ years of pharmaceutical industry experience in CMC Regulatory Affairs, with a focus on small moleculesExperience in leading high-quality CMC regulatory submissions for global marketing applicationsStrong knowledge of global regulatory guidelines (FDA, EMA, ICH)...
Insourced Solutions for Tax - Controversy & Regulatory Senior Manager
As a Senior Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. Our Tax Controversy and Regulatory Services team helps our clients navigate the Internal Revenue Service process to facilitate compliance, drive issue resolutio...
Regulatory Affairs Manager
Key Responsibilities:Develop and implement regulatory strategies for global medical device clearances and approvalsManage regulatory submissions and communications with FDA and EU notified bodiesProvide regulatory guidance to cross-functional teams throughout the product lifecycleRequired Qualificat...
Fair Lending and Compliance Specialist
The Fair Lending and Compliance Specialist is primarily responsible for administering monitoring programs under the Company's compliance management system to assist in managing compliance and fair lending risk across the organization. Support the Compliance Management System established by the Chief...
Senior Regulatory Compliance Specialist
A company is looking for a Senior Regulatory Compliance Specialist to assist with the implementation and maintenance of its Compliance Software Program. ...
Regulatory Compliance Specialist
Commonwealth Engineers seeks an experienced Regulatory Compliance Specialist to join our award-winning engineering design and consulting firm. Communicate compliance and enforcement schedule progress to regulatory agencies. Previous experience with Local, State, and/or Federal Environmental/Regulato...
Regulatory Specialist
The Regulatory Specialist is responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations and listings. Stay abreast of regulatory procedures and changes in regulatory climate. Support external regulatory agency audits, providing regulatory input to...
Regulatory Compliance Specialist
Regulatory Compliance Specialist – Lafayette, IN - $60k - $75k/year. Aegis Worldwide is seeking a Regulatory Compliance Specialist to lead and manage investigations into potential violations of laws, regulations, and Subaru policies. This role is responsible for tracking and analyzing compliance ris...