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Job Title: Regulatory Affairs Executive
Company: Stanex Drugs and Chemicals Pvt Ltd
Location: Hyderabad – Cherlapally, Phase III
Experience: 0–2 years
Salary Range: 2 LPA to 3 LPA
Bond: 2 Years
Gender Requirement: Male candidates only
About the Role
Stanex Drugs and Chemicals Pvt Ltd is seeking a motivated and detail-oriented Regulatory Affairs Executive to join our team. You will be responsible for ensuring our API and injectable products meet all local and international regulatory requirements. This role involves close collaboration with R&D, Quality Assurance, and Quality Control teams to support product development and ensure compliance.
Key Responsibilities
• Prepare and submit regulatory dossiers for API and injectable products.
• Coordinate with regulatory authorities to obtain necessary approvals.
• Ensure compliance with local (CDSCO) and international (USFDA, ICH, etc.) pharmaceutical regulations.
• Review, update, and maintain regulatory documentation to meet quality standards.
• Monitor global and domestic regulatory changes and implement required updates.
• Collaborate with cross-functional teams (R&D, QA, QC) to support regulatory submissions.
Qualifications & Skills
• Education: B.Pharm or M.Pharm.
• Experience: 0–2 years in Regulatory Affairs, preferably in API or injectable formulations.
• Knowledge: Strong understanding of regulatory guidelines such as ICH, USFDA, and CDSCO.
• Skills: Proficiency in dossier preparation, excellent communication, attention to detail, and ability to work with cross-functional teams.
• Location Eligibility: Willingness to work in Hyderabad, Cherlapally Phase III.
• Availability: Immediate joiners or candidates with up to 1-month notice preferred.
• Gender: Male candidates only.