Regulatory Affairs Officer
Job Description
Regulatory Compliance: Ensure the company's products meet all regulatory standards and guidelines across multiple jurisdictions (e.g., FDA, EMA, Health).
Documentation & Filing: Prepare, review, and submit regulatory documents including registration dossiers, technical files, and regulatory submissions.
Regulatory Strategy: Develop and implement regulatory strategies for new products, product changes, and product life cycles to ensure timely approval.
Cross-Functional Collaboration: Work closely with R&D, Quality Assurance, Manufacturing, and Marketing teams to ensure regulatory requirements are integrated into all stages of product development.
Market Surveillance: Monitor ongoing changes in regulations and standards, ensuring all required updates and adjustments are made to company policies and practices.
Regulatory Affairs Reporting: Provide regular updates to senior management on the status of regulatory submissions, approvals, and compliance activities.
Audits & Inspections: Support preparation for regulatory inspections and audits, ensuring all required documentation and processes are in place.
Need experience with CDSCO registration and ISO
Job Type: Full-time
Pay: ?13,823.49 - ?250,000.00 per month
Benefits:
• Health insurance
• Provident Fund
Schedule:
• Day shift
Experience:
• total work: 1 year (Preferred)
Work Location: In person
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Job Detail
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Job IdJD3506117
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IndustryNot mentioned
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Total Positions1
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Job Type:Contract
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationMH, IN, India
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EducationNot mentioned
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ExperienceYear