Prepare and coordinate the compilation and/or submission of documents to regulatory agencies in supp. ...
Assist in preparing product dossiers for regulatory submission to regulatory. Prepare and coordinate the compilation and/or submission of documents to regulatory agencies in support of maintenance and compliance requirements as well as development projects. You will be the primary contact and provid...
Regulatory Affairs Associate I. Help determine regulatory strategies for manufacturing changes and regulatory activities. A Master's Degree in Regulatory Affairs with a minimum of 3 months of regulatory experience (internship) is required. Coordinate and track workflows for regulatory submissions. ...
Regulatory Affairs Associate I. Help determine regulatory strategies for manufacturing changes and regulatory activities. A Master’s Degree in Regulatory Affairs with a minimum of 3 months of regulatory experience (internship) is required. Coordinate and track workflows for regulatory submissions. ...
Internal regulatory support for operation and control eg:Review and approval of Lonza Regulatory Intelligence Bulletin, Interpretation of EU, US and other global regulatory requirements to support compliance in all phases of contract manufacturing of biological products and maintain transparency of ...
Help determine regulatory strategies for manufacturing changes and regulatory activities. A Bachelor’s degree in a scientific field, preferably Chemistry or Pharmacy, with - years of experience, or a Master’s Degree in Regulatory Affairs with a minimum of months of regulatory experience (internship)...
Help determine regulatory strategies for manufacturing changes and regulatory activities. Degree in Regulatory Affairs with a minimum of months of regulatory experience (internship) is required. Help determine regulatory strategies for manufacturing changes and regulatory activities. Degree in Regul...
Corporate/Regulatory Associate. Our corporate/commercial health practice offers general counsel, health regulatory and governance advice to healthcare organizations, associations and professionals. We provide strategic advice and regulatory opinions on a wide variety of issues. ...
Help determine regulatory strategies for manufacturing changes and regulatory activities. Bachelor’s degree in a scientific field, preferably Chemistry or Pharmacy, with 1-3 years of experience, or a Master’s Degree in Regulatory Affairs with a minimum of 3 months of regulatory experience (internshi...
Represent regulatory CMC on and/or lead matrix teams for small molecule pipeline products and/or commercial products through completion of post-marketing commitments and relevant lifecycle management projects driven by research. Independently provide strategic guidance/input related to current regul...
Responsible for reporting monthly adjustments and corrections to the Compliance Manager. ...
The successful candidate will partner with internal and external stakeholders, including vendors and third-party assessment organizations (3PAOs), to ensure remediation is completed, controls are implemented and documented in accordance with FedRAMP compliance standards, and SLAs are met. Perform co...
Submits product labeling in compliance with legal/regulatory requirements and communicates planned/approved changes with operations, commercial, medical affairs and marketing. Has recognized regulatory expertise and extensive knowledge of regulatory requirements and regulations with ability to strat...
Director of Regulatory Affairs Body Contouring and Regulatory Innovation MPS. Directs and supports development of the regulatory strategy related to MPS activities for device regulatory activities in a variety of counties including but not limited to US, EU, US, Japan, and China. Supports regulator...
Assist in the preparation of regulatory submissions in support of IVDR implementation of Toxicology and Therapeutic Drug Monitoring Assays. Organize and assist in the review of materials for inclusion in regulatory submissions both in the EU and worldwide. Support the preparation of dossiers and sub...
Manager in Regulatory Affairs is responsible for developing and managing regulatory strategies to remain compliant with U. Extensive knowledge of regulatory requirements, including ICH and regional requirements and an understanding of current global and regional trends in regulatory affairs. FDA and...
The Environmental Compliance Specialist is responsible for coding environmental commitments from environmental and permit approval documents into the Authority's Environmental Management and Mitigation Assessment database application (EMMA), preparing reports in EMMA to identify gaps and document mi...
As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the regulatory department, ensuring efficient and compliant business processes and environment. Principal Regulatory Affairs Specialist. This position performs specialized level work assignm...
As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the regulatory department, ensuring efficient and compliant business processes and environment. We are seeking a **Principal Regulatory Affairs Specialist** to join Abbotts Heart Failure Div...
As an individual contributor, this position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Prepares robust ...
As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the regulatory department, ensuring efficient and compliant business processes and environment. Principal Regulatory Affairs Specialist. This position performs specialized level work assignm...
Workers' Compensation Audit & Compliance Specialist. This position exists to ensure that claims are handled in compliance with the best practices and procedures compliant with applicable state laws. Designs and recommends compliance policies, processes and procedures for multi-jurisdictions states a...
Alternative Education and Experience Requirement: Bachelor’s degree in Medical Device and Diagnostics Engineering, Regulatory Affairs/Compliance, Biology, Chemistry, or related field of study plus 8 years of experience in IVD Regulatory Affairs or Medical Device Regulatory Affairs as a Regulatory Af...
As an International Regulatory Project Manager, you will be a member of CDx International CDx within the International Regulatory Chapter. Provide input to project and product regulatory strategy based on international regulatory requirements and support international regulatory submissions by provi...
As an International Regulatory Project Manager you will be a member of CDx International CDx within the International Regulatory Chapter. Provide input to project and product regulatory strategy based on international regulatory requirements and support international regulatory submissions by provis...