Regulatory Affairs Consultant

Company Description GESCO Healthcare is a leading manufacturer and exporter of spinal, orthopaedic, and CMF implants and surgical instruments in the Asia-Pacific region. With over 60 years of experience, GESCO has transformed the lives of over 120 million people. The company's innovation center leads the way in developing path-breaking and cost-effective...

Company Description GESCO Healthcare is a leading manufacturer and exporter of spinal, orthopaedic, and CMF implants and surgical instruments in the Asia-Pacific region. With over 60 years of experience, GESCO has transformed the lives of over 120 million people. The company's innovation center leads the way in developing path-breaking and cost-effective...

**Job highlights** - Years of Experience: Minimum 5 Years in Medical Device/ Pharma/ Life science. Qualification: M Sc Life Science/ BTech Medical / B Pharm/ M Pharm. - Minimum of 2-3 years of experience in regulatory affairs Healthcare industry, with specific experience in USFDA / 510K submission and MDSAP Audit preparation **Job description** This is a...

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 regulatory requirements...

Experience: 0 to 1 years of experience in Regulatory affairs. Qualification: B. Pharm / M. Pharm / MSc. Biotechnology Description: Regulatory Affairs Handling Dossiers License Queries CFT Communication Life cycle etc. *Immediate Joiners* Excellent in Communication Application Question(s): - Current CTC - Expected CTC - Notice...

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...

Full job descriptionThis role involves preparing, submitting, and managing regulatory documentation and applications to gain approval for products.Key Responsibilities:Prepare and submit regulatory applications to ensure timely approvals for new and existing products.Monitor and stay up-to-date on regulatory changes and requirements in different...

Regulatory Compliance Consultant Part time advisory on regulatory compliance for lending software suite covering LOS and LMS in order to safeguard interest for Banks and NBFC’s. Keep constantly updated on the latest set of regulatory guidelines that needs to conform with by NBFC’s and banks in their lending process and practices across all types of loans...

Full job description **Key Responsibilities**: - Monitor and stay up-to-date on regulatory changes and requirements in different regions. - Communicate with regulatory authorities and answer their queries or requests. - Ensure product labeling and packaging meet regulatory standards. - Maintain records of regulatory submissions, approvals, and...

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...