Executive – Regulatory Affairs

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...

Reporting to: Assistant Manager – Regulatory Affairs Division: Ortho Implants Location: Chennai No. of Positions: 1 Education: B.E/ B. Tech in Biomedical Engineering / M. Pharm Regulatory Affairs Experience: 2 - 4 years Exp. in ‘scientific writing / clinical documentation’ role preferred KEY RESPONSIBILITIES: Technical writing, literature...

Preferred Experience:2-15 Years in Pharmaceutical industry with major experience in Global Regulatory Affairs function. Authoring and/or contributing line to CMC content for New Development & Post-approval Variations/ Supplements for Chemical Entities, Biologicals, Vaccines (INDs/ IMPDs/ NDAs/ BLAs/ ANDAs/ MAAs/) & Medical Devices (PMA/ 510(K)/ Notified...

Preferred Experience: 2-15 Years in Pharmaceutical industry with major experience in Global Regulatory Affairs function. Authoring and/or contributing line to CMC content for New Development & Post-approval Variations/ Supplements for Chemical Entities, Biologicals, Vaccines (INDs/ IMPDs/ NDAs/ BLAs/ ANDAs/ MAAs/) & Medical Devices (PMA/ 510(K)/ Notified...

HCL Technologies is a next-generation global technology company that helps enterprises reimagine their businesses for the digital age. Our technology products and services are built on four decades of innovation, with a world-renowned management philosophy, a strong culture of invention and risk-taking, and a relentless focus on customer relationships. HCL...

HCL Technologies is a next-generation global technology company that helps enterprises reimagine their businesses for the digital age. Our technology products and services are built on four decades of innovation, with a world-renowned management philosophy, a strong culture of invention and risk-taking, and a relentless focus on customer relationships. HCL...

Why Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate...

Committed to quality and excellence in compliance and conformance With the reasonable understanding of regional regulations, would perform the evaluation of the notifications assigned. Accountable for maintaining the HA status in corporate change and dossier management system for the allocated Regions / Markets Contributes independently and manages...

Committed to quality and excellence in compliance and conformance With the reasonable understanding of regional regulations, would perform the evaluation of the notifications assigned. Accountable for maintaining the HA status in corporate change and dossier management system for the allocated Regions / Markets Contributes independently and manages own...

HCL Technologies is a next-generation global technology company that helps enterprises reimagine their businesses for the digital age. Our technology products and services are built on four decades of innovation, with a world-renowned management philosophy, a strong culture of invention and risk-taking, and a relentless focus on customer relationships. HCL...

HCL Technologies is a next-generation global technology company that helps enterprises reimagine their businesses for the digital age. Our technology products and services are built on four decades of innovation, with a world-renowned management philosophy, a strong culture of invention and risk-taking, and a relentless focus on customer relationships. HCL...

HCL Technologies is a next-generation global technology company that helps enterprises reimagine their businesses for the digital age. Our technology products and services are built on four decades of innovation, with a world-renowned management philosophy, a strong culture of invention and risk-taking, and a relentless focus on customer relationships. HCL...

Committed to quality and excellence in compliance and conformance. - With the reasonable understanding of Regional Regulations, would perform the evaluation of the notifications assigned. - Accountable for maintaining the RA status in corporate change and dossier management system for the allocated Regions / Markets - Contributes independently and manages...

Why Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate...

Committed to quality and excellence in compliance and conformance. • With the reasonable understanding of Regional Regulations, would perform the evaluation of the notifications assigned. • Accountable for maintaining the RA status in corporate change and dossier management system for the allocated Regions / Markets • Contributes independently...

Committed to quality and excellence in compliance and conformance. • With the reasonable understanding of Regional Regulations, would perform the evaluation of the notifications assigned. • Accountable for maintaining the RA status in corporate change and dossier management system for the allocated Regions / Markets • Contributes independently and...

Our people work differently depending on their jobs and needs. From hybrid working to flexible hours, we have plenty of options that help our people to thrive. This role is based in India and as such all normal working days must be carried out in India. Join us as a Regulatory Control Associate - This is a great opportunity to join our business and play a...

Why Patients Need You  We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and...

Responsibility: Functions as support for GRS-CMC to perform the following activities (under supervision) for Nitrosamine assessment:Step 1 Assessment for Nitrosamine riskStep 2 Confirmatory testing Responsible for effective review and providing timely feedback to the GRL/RRL/CRL on technical documents (on a need basis). Remediation Planning:...