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...

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...

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...

**Key Responsibilities**: - **Regulatory Compliance**: Ensure compliance with ISO 13485, EU MDR 2017/745, US-FDA, CDSCO, and other applicable international standards for medical devices. - **Submissions and Approvals**: Prepare, review, and submit regulatory documentation, including 510(k) and IMDR submissions, to regulatory authorities such as US-FDA,...

**Job Title**:Regulatory Affairs and SCM -Executive **Location**:Chennai, India**Employment Type**:Permanent**About OMRON** - Founded in 1933, OMRON has come a long way since and has evolved to become an organization committed to creating new social values. Today, In the APAC region, OMORN has a strong presence in Industrial Automation, Healthcare, and...

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...

Dear Candidates, We have an opportunity with clinical trial development and CRO related assets and capabilities from an existing ACRO/SMO organization that is based in Chennai. We have over 10 years of experience running clinical trials as part of the global Group.  Position OverviewThe Head of Regulatory Affairs is responsible for providing strategic...

Job Description Job Title: Associate Regulatory Affairs Employment Type: Contract Location: Chennai Experience: 06 months Roles and Responsibilities: - Work with local operating companies to provide regulatory review and approval of formulations, raw materials, and their constituent information to ensure completeness, accuracy, and compliance. -...

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...

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...