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Aurolab, a leading pharmaceutical and medical device manufacturer in Madurai, Tamil Nadu, is hiring a Regulatory Affairs Executive. This is a full-time, on-site opportunity for skilled professionals in regulatory affairs, quality assurance, and compliance. If you have experience in handling audits, CAPA, SOPs, and regulatory documentation, this role offers the perfect chance to advance your career in pharma regulatory management.
Key Responsibilities
As a Regulatory Affairs Executive at Aurolab, you will:
- Ensure manufacturing processes comply with regulatory and quality standards.
- Establish and update quality plans, assurance procedures, and technical specifications.
- Maintain and update quality assurance records.
- Handle complaints, lead investigations, and implement CAPA (Corrective and Preventive Actions).
- Collaborate with Production and R&D teams to define and monitor quality objectives.
- Prepare DMR (Device Master Records) and regulatory documentation for new products.
- Co-ordinate with the regulatory team during audits and ensure timely closure of findings.
- Prepare and review SOPs, risk analyses, and MDD (Medical Device Directive) documents.
Qualifications
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related fields.
- 2–5 years of experience in regulatory affairs, QA, or compliance within pharma/medical device industry.
- Strong knowledge of audits, SOP preparation, CAPA, and documentation.
- Excellent communication and problem-solving skills.
Benefits
- Competitive salary package (INR 3,00,000 – 5,00,000 per annum).
- Opportunity to work with a reputed pharma and medical device manufacturer.
- Career growth in regulatory affairs and quality management.
- Exposure to international quality and compliance standards.
How to Apply
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OR Send Resume on ta@aurolab.com
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