Pharmaceutical Regulatory Affairs Advisor Naukri Healthcare Jobs

6.0 - 10.0 years

7 - 11 Lacs

mumbai

Work from Office

We are looking for a skilled Pharmaceutical Regulatory Affairs Advisor with 6-10 years of experience to join our team at Metina Pharmaconsuting, located in the Pharmaceutical & Life Sciences industry. Roles and Responsibility Develop and implement regulatory strategies to ensure compliance with pharmaceutical regulations. Provide expert advice on regulatory affairs, including FDA, EMA, and other global regulatory requirements. Collaborate with cross-functional teams to develop and launch new products. Conduct thorough reviews of regulatory submissions, including clinical trial applications and marketing authorizations. Stay up-to-date with changing regulatory environments and emerging trends...

Posted 13 hours ago

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QA Manager Mantras2success Consultants

1.0 - 6.0 years

4 - 20 Lacs

gandhinagar, maharashtra, india

On-site

Ensure product quality and conformity to regulatory standards, including Medical Device Regulation (MDR) and Quality Management System (QMS). Conduct internal quality audits and participate in management review meetings. Handle investigations of complaints and implement corrective and preventive actions. Maintain and update quality manuals, formats, and standard operating procedures (SOPs) in accordance with ISO 13485:2016. Prepare technical files, including Instructions for Use (IFUs), labeling, packaging information, and patient information leaflets, as per EU MDR 2017/745. Review certificates of analysis (COA), sterilization check sheets, calibration reports, and other relevant documents....

Posted 4 weeks ago

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QA & RA Associate Mantras2success Consultants

0.0 - 4.0 years

3 - 7 Lacs

Ahmedabad, Gujarat, India

On-site

Key Responsibilities: Ensure product quality and conformity to regulatory standards, including Medical Device Regulation (MDR) and Quality Management System (QMS). Conduct internal quality audits and participate in management review meetings. Handle investigations of complaints and implement corrective and preventive actions. Maintain and update quality manuals, formats, and standard operating procedures (SOPs) in accordance with ISO 13485:2016. Prepare technical files, including Instructions for Use (IFUs), labeling, packaging information, and patient information leaflets, as per EU MDR 2017/745. Review certificates of analysis (COA), sterilization check sheets, calibration reports, and oth...

Posted 4 months ago

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