Regulatory Affairs Executive

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,...

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...

Age limit:20 to 30.Clinical Study Design & Execution: Leading the design and implementation of clinical study protocols and monitoring their progress.Regulatory Compliance: Ensuring all activities, from clinical trials to post-market evaluations, adhere to regulatory requirements and guidelines (e.g., FDA regulations, GCP).Data Management & Analysis:...

review and prepare regulatory submissions, including new ANDA filings, amendments and Annual reports to the ANDAReview of DMF; Manages USFDA registration Provides technical review of data and reports to be incorporated into regulatory submissions;

Prepare, review & submission of quality regulatory dossiers in CTD/eCTD format for Europe & other domestic markets. Support product development, registration, & lifecycle management in Europe Manage Regulatory Compliance & Approvals Required Candidate profileMinimum 4 years of exp in Formulation OSD Willing to work in Chennai3.Strong expertise in EU,...

DescriptionRegulator ChemistLocation: Chennai, IndiaRequired Language: EnglishEmployment Type: Full-TimeSeniority Level: AssociateTravel Mode: ModerateAbout UsBuckman is a privately held, global specialty chemical company with headquarters in Memphis, TN, USA, committed to safeguarding the environment, maintaining safety in the workplace, and promoting...

Are you passionate about delivering high-quality medical information and making a meaningful impact in healthcare?Join our team at Scitua Pharma as a Medical Information ExecutiveLocation: Chennai, IndiaRole: Medical Information ExecutiveCompany: Scitus Pharma Private limitedExperience: 0 to 2 Year experience in MICCQualification: PharmD, M. PharmWhat You'll...

Position : Officer - Assistant Manager (Regulatory & Corporate Affairs)Location : Corporate OfficeDepartment : Regulatory & Corporate AffairsReports To : JGMJob PurposeWe are seeking a skilled legal professional to manage regulatory compliance and corporate affairs related to FSSAI. The ideal candidate will have a strong understanding of FSSAI laws and...

Use Your Power for PurposeWe're committed to delivering medicines to the world with greater speed, without compromising on excellence and integrity. Navigating both local and global regulations is crucial, and the dynamic regulatory landscape demands innovative thinking and meticulous attention to detail. Your role will be instrumental in ensuring that our...