Regulatory Affairs Professional

Job OverviewThis role plays a critical part in the success of our organization by ensuring compliance with regulatory requirements and facilitating the efficient approval of drug products.We are seeking a highly skilled Regulatory Affairs Associate to join our team. In this position, you will be responsible for preparing generic drug product submissions for...

Job Title: Regulatory Affairs ManagerAbout the RoleWe are seeking a highly skilled Regulatory Affairs Manager to oversee and manage the preparation, submission, and tracking of regulatory dossiers for product registrations, renewals, and variations across Asia.Key Responsibilities:Conduct thorough regulatory reviews of dossier sections (Quality) to ensure...

Regulatory Affairs Specialist">We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory group, you will play a critical role in ensuring compliance with regulatory requirements and facilitating the approval of our products.">Lead submission for annual reports, facility registrations, facility renewals,...

Regulatory Affairs SpecialistThis is a key role within our organization, responsible for ensuring compliance with regulatory requirements. The Regulatory Affairs Specialist will work closely with cross-functional teams to prepare and submit amendments and supplements for assigned products.Key Responsibilities:Amendment and Supplement Preparation: Prepare,...

Role - Regulatory Affairs - Medical Devices Experience - 1 to 3 Years Location- Madhavaram Chennai Budget - As per the industry Key Responsibilities 1 Regulatory Submissions Prepare and submit regulatory documents to authorities for approval such as new product applications amendments and supplements 2 Compliance Ensure products meet...

Job Description Role - Regulatory Affairs - Medical DevicesExperience - 1 to 3 YearsLocation- Madhavaram, ChennaiBudget - As per the industryKey Responsibilities:1. Regulatory Submissions: Prepare and submit regulatory documents to authorities for approval, such as new product applications, amendments, and supplements.2. Compliance: Ensure products meet...

About the roleWe are seeking a seasoned Regulatory Affairs professional to manage end-to-end preparation and submission of Abbreviated New Drug Applications (ANDAs) and related post-approval submissions.Manage cross-functional teams to collect required data and documentation for timely regulatory submissions.Compile CMC documentation in compliance with FDA...

Job Summary:","Regulatory Affairs Specialist: Artwork Management and Compliance"],

Regulatory Affairs Specialist Job OpportunityThe ideal candidate for this position will have a strong background in regulatory affairs, with a focus on CMC and USFDA submissions.A key responsibility of the role is leading and managing CMC regulatory activities, including preparing and reviewing technical documents such as Module 2 & 3 (CTD format).Key...

Our team seeks a strategic Regulatory Affairs Professional to join our global network. The ideal candidate will be responsible for implementing regulatory strategies and managing operational activities in assigned regions. They will provide input into global regulatory strategy, contribute to the Regulatory Functional Plan (RFP) and Seed Document, and...