Opportunity for Regulatory Affairs Officers

Cologenesis Healthcare as a Regulatory Affairs Officer in Salem, Tamil Nadu

Are you an experienced regulatory professional looking for a rewarding career in the pharmaceutical industry? Cologenesis Healthcare, a leading name in the healthcare sector, is seeking a Regulatory Affairs Officer to join their team in Salem, Tamil Nadu. If you have a background in M.Pharm, B.Pharm, or Pharm.D and 2+ years of experience in regulatory affairs, this is an excellent opportunity to advance your career.

Key Responsibilities

CDSCO Portal Management

• Handle licensing procedures via the Indian Central Drugs Standard Control Organization (CDSCO) portal.
• Respond to inquiries and ensure compliance with regulatory requirements.

Export Registration

• Manage the end-to-end process for export registration of pharmaceutical products.
• Ensure compliance with international regulatory guidelines.

Regulatory Documentation

• Prepare and submit comprehensive regulatory dossiers for product approvals.
• Maintain up-to-date documentation as per government norms and industry standards.

Outsourced Testing Evaluation

• Assess and review reports from third-party testing facilities.
• Ensure accuracy and compliance with regulatory standards.

Import/Export Operations

• Oversee the logistical and regulatory aspects of importing and exporting pharmaceutical products.
• Work closely with authorities to ensure smooth operations.

Required Qualifications & Experience

• Educational Qualification: M.Pharm, B.Pharm, or Pharm.D.
• Experience: Minimum 2 years in regulatory affairs within the pharmaceutical industry.
• Skills Required:
  • Strong knowledge of CDSCO regulations.
  • Proficiency in regulatory documentation and compliance.

How to Apply?

Interested candidates can apply via LinkedIn: Apply Here

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