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Senior Regulatory Compliance Specialist

3 weeks ago

Vizag, Andhra Pradesh, India beBeeExpert Full time ₹ 17,51,146 - ₹ 21,48,613
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**Regulatory Affairs Expert Wanted**

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At our organization, we are seeking an experienced Regulatory Affairs professional to join our team.

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The successful candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.

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  • Regulatory Filings: Prepare, review, and submit regulatory documents to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines).\
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  • Compliance Management: Ensure adherence to international, federal, and local regulatory requirements across pharmaceuticals and medical devices.\
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  • Regulatory Strategy Development: Develop and maintain regulatory strategies to support new product development and lifecycle management.\
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  • Labeling and Promotional Materials: Review labeling, promotional materials, and product packaging for compliance with applicable regulations.\
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  • Regulatory Knowledge Management: Maintain up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.\
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  • Collaboration and Quality Assurance: Collaborate with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development and support quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.\
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  • Regulatory Documentation and Compliance Records: Manage regulatory documentation archives and maintain compliance records for audits and inspections.\
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