Job Opportunity: Sr. Executive / Manager – Regulatory Affairs at Zenotech Laboratories Limited

Job Summary

Zenotech Laboratories Limited is seeking a detail-oriented and experienced professional to join our team in Hyderabad as a Senior Executive or Manager in Regulatory Affairs. This role is ideal for candidates with a background in pharmaceuticals who are looking to advance their careers in regulatory affairs and liaisoning. The successful candidate will manage regulatory submissions for Oral Solid Dosage (OSD), non-oral dosage forms, and biologics, ensuring full compliance with evolving Indian regulatory requirements. If you are a proactive professional with strong communication skills and a deep understanding of regulatory portals, we invite you to apply.

Job Overview

• Company: Zenotech Laboratories Limited
• Location: Hyderabad, India
• Role: Sr. Executive / Manager – Regulatory Affairs
• Department: Regulatory Affairs / Liaisoning
• Unit Focus: Formulation (Orals / Non-Orals / Biologics)
• Experience: 4 – 8 Years
• Qualification: B.Pharm / M.Pharm
• Employment Type: Full-Time, Permanent

Job Description

As a Regulatory Affairs specialist, you will play a vital role in the lifecycle of our pharmaceutical products. You will be responsible for the preparation, review, and submission of high-quality regulatory dossiers. This role requires a blend of technical documentation expertise and strong liaisoning skills to ensure seamless communication with regulatory authorities. You will serve as the primary point of contact for submission-related activities, ensuring that all documentation meets the standards required for the Indian market.

Key Responsibilities

• Regulatory Submissions: Execute the preparation and submission of regulatory applications through relevant government online portals.
• Portal Management: Demonstrate advanced proficiency in utilizing the ODLS (Telangana) and ONDLS portals for regulatory filings.
• Dossier Management: Lead the preparation, critical review, and maintenance of comprehensive regulatory dossiers for Orals, Non-Orals, and Biologics.
• Liaisoning: Actively track the status of applications and maintain professional, effective coordination with regulatory authorities to expedite approvals.
• Compliance: Manage product licenses, handle inspection-related documentation, and ensure all internal records remain up to date.
• Cross-Functional Collaboration: Work closely with internal departments (such as QA, QC, and Production) to ensure all data required for submissions is accurate and provided on time.
• Regulatory Intelligence: Stay current with shifting regulatory guidelines and proactively update internal processes to maintain ongoing compliance.

Requirements

• Education: A Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm) is mandatory.
• Experience: A minimum of 4 to 8 years of dedicated experience in the pharmaceutical regulatory affairs sector.
• Technical Proficiency: Extensive hands-on experience with the ODLS and ONDLS portals.
• Regulatory Knowledge: Deep understanding of the Indian regulatory landscape and current compliance requirements.
• Soft Skills: Strong analytical, documentation, and interpersonal skills. The ability to manage tight deadlines and navigate complex regulatory environments is essential.

Benefits

• Competitive Compensation: An attractive salary package ranging from ₹6 LPA to ₹12 LPA, commensurate with your experience and specific role level.
• Professional Development: Gain exposure to a wide variety of dosage forms, including specialized biologics.
• Career Growth: Work within a reputable pharmaceutical organization that fosters professional advancement and continuous learning.
• Work Environment: Join a stable, high-standard professional environment that values compliance, integrity, and operational excellence.

How to Apply

If you meet the above requirements and are interested in joining the Zenotech Laboratories team, please submit your updated resume to our Human Resources department. Ensure your application includes your total years of experience, current CTC, and expected notice period.

Note: Please reach out to the Zenotech Laboratories official career portal or the HR contact provided on our company website to submit your application and supporting documents.