Job Opening: Executive/Sr. Executive – Regulatory Affairs & Compliance
- Company: Synbiotics Ltd.
- Location: Luna, Padra, Vadodara
- Department: Regulatory Affairs
- Experience: 2 to 8 Years
- Qualifications: B.Sc/B.Pharm/M.Sc/M.Pharm
Key Responsibilities
Regulatory Affairs
- Manage and facilitate all regulatory filings with national and international regulatory bodies.
- Review and prepare documentation for regulatory submissions, including validation procedures and stability studies.
- Respond to queries from regulatory authorities regarding submitted dossiers.
- Support corporate regulatory affairs in filing activities and compliance formalities.
- Assist other group companies with regulatory filings as needed.
Regulatory Compliance
- Stay informed on the latest regulatory changes and ensure compliance with all regulatory and customer audit requirements.
- Ensure Good Laboratory Practice (GLP) compliance within the Quality Control department.
- Review and approve critical procedures, documents, and analytical method validation records.
- Oversee the review of laboratory incidents, out-of-trend results, and out-of-specification findings.
- Monitor the calibration and validation status of all Quality Control instruments and equipment.
- Facilitate the review of batch testing records and address audit/inspection findings related to Quality Control functions.
- Participate in internal audits and self-inspections alongside Quality Assurance teams.
- Perform additional responsibilities as assigned to meet organizational needs.
How to Apply
Interested candidates can send their CVs to hrd@synbiotics.in
