Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality..., and responses to regulatory authority questions. Ensure compliance with FDA, EMA, and ICH guidelines and internal processes...
to facilities, validation, environmental monitoring, cGMP manufacturing, QA/QC for biological products, compliance and/or regulatory... worldwide regulatory product registration strategies, prepare complex registration dossiers, establish and maintain tracking...
Work Flexibility: Hybrid Senior Manager, Regulatory Affairs – Joint Replacement Division Location: Hybrid – Mahwah..., NJ As the Senior Manager, Regulatory Affairs, you will provide leadership and coordination of the Joint Replacement...
studies. Ensures compliance with local, state, and federal laws; accreditation, professional and regulatory agency standards... will be challenging, but always rewarding. It’s Work That Matters. Overview Purpose Statement/Position Summary: The Manager, Clinical...
Manager is one of enforcing current Good Manufacturing Practices (cGMP), ensuring compliance to FDA regulations, communicating.... Core Responsibilities Enhances cGMP and FDA regulatory compliance and assists in preparation and maintenance of standard...
a seasoned Compliance Manager or Director of Compliance to lead regulatory compliance across multiple product categories...Title: Compliance Manager Location: Lodi, NJ or Oklahoma City offices Compensation: up $140K Bonus/ Incentives...
Role : Telecom Interconnection & Regulatory Program Manager Location: Dallas TX or Atlanta GA (Onsite) Duration: 6... and amendments Collaborate with stakeholders to align agreements with regulatory compliance and business objectives...
to require a full-time, in-office schedule at any time based on business needs. Regulatory Reports Manager Responsible... for overseeing the Bank’s compliance with regulatory reporting requirements, includes, but not limited to Currency Transaction...
compliance with international standards, guiding partners and stakeholders through complex regulatory environments. Quality... with diverse experience, backgrounds, and culture. Team Overview The Product Development, Quality, Costing, and Regulatory...
Manager to join our Office of Regulatory Relations team. This role is located in Pittsburgh, PA Role Summary: The Office... for regulatory interactions, and guides the firm to speak with one voice. As an Associate Relationship Manager, you will provide...
Job Description: The Senior Regulatory Affairs Manager will play a crucial role in leading and managing the regulatory... submissions, including 510(k) and submissions. This individual will ensure compliance with all applicable regulations in the...
reviews, advocacy, risk analysis, and collaborative resolutions that uphold regulatory compliance and drive member... to simplify health care one person, one family and one community at a time. The Regulatory Resolution Team is responsible...
Responsibilities: Responsible for providing guidance to ensure that all regulatory submissions are planned..., communicated, and performed per regulatory and business requirements. In addition, this position serves as a subject matter expert...
We are seeking a talented individual with regulatory affairs knowledge/experience and interpersonal skills... to join our RII TG, Global Regulatory Strategy team. As a valued member of the Regulatory Matrix Team and the asset project teams...
as a practicing attorney at a leading law firm or corporation as a regulatory compliance, transactional and/or litigation attorney... team at a top global hospitality company! As a Counsel, Franchise & Regulatory, you will support the team guiding Hilton...
. As Regulatory and Certification Lead, you will shape the certification strategy for novel automated aircraft and operations, working... aircraft are approved, deployed, and scaled globally. Certification & Regulatory Leadership: Own, with the VP, the end...
a robust, effective Quality Management System and security & regulatory compliance effort that aligns with Cencora' s policy... of compliance and will facilitate knowledge transfer throughout the operation to help build a Quality and Regulatory Compliance...
and related documentation to assure collection of appropriate data for regulatory submissions and regulatory compliance. Write... Summary This position will be working in BD-Connected Care on Regulatory Affairs projects that support the Pharmacy...
for managing regional wide Regulatory Performance Improvement programs that monitor compliance to federal and state mandates, CMS... Professional (CJCP) within three (3) years of hire or transfer to role. PREFERRED QUALIFICATION(S): Regulatory experience...
, programs and performance objectives. 40% Planning and Reporting Manages the overall regulatory process, including the... development of Term Reports, Compliance Filings, and Three-Year Plans in support of the Company’s energy efficiency programs...