Regulatory Affairs Specialist

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,...

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...

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...

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,...

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...

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...

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...

Job Title: Regulatory Partnership SpecialistWe are seeking a skilled professional to serve as our primary point of contact with regulatory bodies and industry associations.Main Responsibilities:Serve as liaison with regulatory bodies, insurance companies, and government agencies.Oversee statutory compliances, audits, and regulatory filings to ensure seamless...

Job Title: Regulatory Compliance SpecialistWe are seeking a highly skilled Regulatory Compliance Specialist to join our team. The key objective of this role is to prepare, review, and maintain regulatory documents to ensure compliance with international guidelines and country-specific requirements.The role involves coordination with internal teams and...

JOB DETAILS Candidates should review and prepare regulatory submissions, including new ANDA filings, amendments and Annual reports to the ANDA.Review of DMF Manages USFDA registration activities FUNCTIONAL AREA Pharma Jobs Consultancy in Chennai, Pharma Jobs Consultancy near me, Pharma Jobs, Top, Best, Jobs Consultancy in Chennai, regulatory affairs jobs...