Key Responsibilities:Manage CMC aspects of small molecule and biologic products in developmentAuthor and review regulatory submissions and responses to health authoritiesLead regulatory section revisions and contribute to risk assessmentsRequired Qualifications:Bachelor's degree in life sciences, pr...
Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures requi...
The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures r...
A company is looking for a Regulatory Affairs Manager - Biosimilars. ...
The In Vitro Diagnostic (IVD) Regulatory Affairs (RA)Team along with the Regulatory Affairs Global Regulatory Strategy Group (GRS) collaborate with the Precision Medicine and Clinical Sciences Teams to help develop and execute biomarker strategies across its growing clinical portfolio. Manager, Regu...
Manage regulatory correspondence mainly to CDER, FDA, User fee staff, drug listing and Board of Pharmacies for state licensing submissions. Provide regulatory guidance to R&,D, Technical Operations Sales and Marketing, Quality, Clinical, Legal. Provide guidance and advise management regarding improv...
Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures requi...
Interpret and communicate regulatory requirements, guidelines, and expectations related to CMC to internal stakeholders, ensuring alignment with global regulatory strategies and objectives. Proactively identify regulatory risks, opportunities, and challenges related to CMC activities and provide str...
The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures r...
Rapidly growing world-class manufacturer providing high-quality, effective products for health and wellness is seeking a Regulatory Affairs Manager to support the business operations in the areas of regulatory compliance. This role will be responsible for planning, coordinating, and implementing reg...
The In Vitro Diagnostic (IVD) Regulatory Affairs (RA)Team along with the Regulatory Affairs Global Regulatory Strategy Group (GRS) collaborate with the Precision Medicine and Clinical Sciences Teams to help develop and execute biomarker strategies across its growing clinical portfolio. Manager, Regu...
Provides leadership to Operations team members, supervisors, and managers by communicating and guiding toward achieving department objectives. Manages daily operations of multi-physician practice(s)/hospital services for a Department/Division or Service Line. Manages staff and processes of multiple ...
A company is looking for a Global Regulatory Affairs Specialist. ...
A company is looking for a Senior Product Manager, Program Management. ...
A company is looking for a Trade Compliance Analyst I. ...
A company is looking for a Program Manager - Software and Data Accreditation. Key Responsibilities:Develop, manage, and maintain programs to ensure compliance with accreditation and regulatory standardsAct as a resource for staff and consult departments on accreditation mattersParticipate in survey ...
A company is looking for a Manager, Product Management Operations. ...
A company is looking for a Global Compliance Project Manager Software Localization. Key Responsibilities:Provide expert guidance on regulatory compliance mattersConduct assessments to identify compliance gaps and develop action plansTrack project deliverables and drive improvement initiativesRequire...
A company is looking for a Regulatory & Compliance Specialist in the healthcare ecosystem. Key Responsibilities:Track state and federal legislation and regulations affecting clientsUpdate bills and rules in the online softwareMonitor Board of Pharmacy websites for relevant informationRequired Qualif...
A company is looking for an Associate Director, Regulatory Affairs. ...
A company is looking for a FedRAMP Consulting Manager. ...
A company is looking for a Marketing Operations Campaigns Manager. ...
A company is looking for a Tax Analyst to work remotely in Cedar Rapids, Iowa. ...