Regulatory Affairs Associate

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 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 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...

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...

**Job Title:** Regulatory Compliance AssociateWe are seeking a highly motivated and detail-oriented individual to join our team as a Regulatory Compliance Associate. In this role, you will be responsible for maintaining the corporate change and dossier management system, PDM, and ensuring compliance with internal SOPs and policies.**Responsibilities:Conduct...

Position: Manager – Corporate Affairs & CommunicationLocation: Oragadam, Chennai , India​ Key Responsibilities:Government Liaison: Serve as the primary point of contact between Vikram Solar and governmental bodies, ensuring effective communication and fostering strong relationships with local and state authorities in Tamil Nadu, and other states and...

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...