Regulatory Affairs Executive

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...

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 search,...

**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...

**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...

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 Title: Associate – Regulatory Affairs Employment Type: Contract (Duration: 1 year)Location: ChennaiExperience: 0–6 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...

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...