Regulatory Affairs Executive

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...

Job Description: Regulatory Affairs Executive (ROW Markets)Industry: PharmaceuticalsExperience: 3-5 YearsLoaction: ChennaiKey Responsibilities:Dossier Submissions: Compile & submit ACTD, CTD, and country-specific dossiers for ROW markets.Regulatory Queries: Prepare and respond to health authority queries on submitted dossiers.Document Review: Review BMR,...

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,...

Regulatory Affairs Opportunities">Candidates seeking a challenging role in regulatory affairs will find this position appealing.The ideal candidate will be responsible for preparing and submitting regulatory documents, including new drug applications (NDAs) and annual reports. Additionally, they will manage US FDA registration activities and oversee the...

Company OverviewRegTrac is a leading healthcare regulatory partner specializing in Global Regulatory Affairs, Quality Systems, and Compliance for Medical Devices, Cosmetics, and Consumer Products. With expertise in navigating regulatory requirements across diverse markets, RegTrac empowers MedTech companies to innovate and expand globally while ensuring...

Job Title: Senior Regulatory Affairs Team Lead Medical DevicesLocation: Chennai, IndiaDepartment: Regulatory AffairsExperience Required: Minimum 5 yearsReports To: Head of Regulatory Affairs / Director of Quality & RegulatoryJob Summary:We are seeking a highly skilled and experienced Senior Regulatory Affairs Team Lead to manage and lead our regulatory...

Regulatory Affairs PositionManage regulatory submissions, including new drug applications (NDAs), complete response letters (CRLs), information requests (IRs), and amendments to existing NDAs.File post-approval and prior approval supplements in compliance with FDA regulations.Review change controls to assess their impact on regulatory alignment and ensure...

Regulatory Submission Expert Job Description: As a Regulatory Affairs professional, you will play a crucial role in ensuring the successful submission of regulatory documents for pharmaceutical products. This includes preparing and reviewing new ANDA filings, amendments, and Annual reports to the ANDA. Key Responsibilities: 1. Prepare and review regulatory...

Job Title:Senior Assistant Director">Job Description:Our organization seeks a highly skilled and motivated professional to lead and manage activities in the Food Regulatory Affairs department.">Key Responsibilities:Drive policy initiatives to support the food industry.Engage with government departments, industry stakeholders, and generate...

JOB DETAILS Manages, reviews, and authors regulatory submissions, including new ANDA filings, complete response letters (CRLs), information requests (IRs), and amendments to existing ANDAs.Responsible for filing Post-Approval and Prior Approval Supplements in compliance with FDA requirements.Reviews change controls to assess regulatory impact and ensure...