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
Job Summary Table
Company Name | Current Vacancies | Required Education | Experience Required |
---|---|---|---|
Cologenesis Healthcare | Regulatory Affairs Officer | M.Pharm, B.Pharm, Pharm.D | Minimum 2 years |