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Regulatory Affairs Officer

Viharsh Lifescience Private Limited

Bopal, Ahmedabad, Gujarat

Department: Regulatory Affairs

Experience: 1-5 Years

Industry: Pharmaceutical

Education: BPharm

Job Description

Regulatory Affairs Officer – Regulatory Affairs | Viharsh Lifescience Private Limited | Ahmedabad, Gujarat, India

Viharsh Lifescience Private Limited is inviting applications for the role of Regulatory Affairs Officer at its Ahmedabad location. This position is designed for professionals who possess a strong understanding of pharmaceutical regulatory processes and documentation standards. The Regulatory Affairs Officer will be responsible for supporting product registration, maintaining regulatory documentation, and ensuring that pharmaceutical products comply with national and international regulatory requirements. Candidates with 1 to 5 years of experience in regulatory affairs within the pharmaceutical industry will find this role suitable for advancing their careers. The position involves collaboration with manufacturing, quality assurance, and research teams to ensure that all regulatory submissions meet industry standards. The selected candidate will contribute to the successful registration and compliance of pharmaceutical products across multiple markets.

Location

Ahmedabad, Gujarat, India

Employment Type

Full-time

Experience Required

1 to 5

Compensation & Benefits

Competitive salary package with opportunities to work in regulatory documentation, product registration, and international compliance.

About Viharsh Lifescience Private Limited

Viharsh Lifescience is a pharmaceutical company focused on delivering quality healthcare products through strong regulatory compliance and innovation. The company operates with a commitment to meeting regulatory standards across domestic and international pharmaceutical markets.

Position Overview

The Regulatory Affairs Officer will support regulatory documentation, submission preparation, and compliance monitoring for pharmaceutical products.

Key Responsibilities

  • Prepare regulatory dossiers and documentation for product registration.
  • Maintain regulatory records and compliance files.
  • Coordinate with quality and manufacturing teams for regulatory data.
  • Monitor regulatory guidelines and update internal documentation.
  • Support product approvals and submission processes.
  • Ensure documentation compliance with regulatory authorities.
  • Assist in preparing responses to regulatory queries.
  • Review product labels and packaging for compliance.
  • Maintain regulatory databases and records.

Required Skills & Competencies

  • Strong knowledge of pharmaceutical regulatory frameworks.
  • Experience preparing regulatory dossiers.
  • Understanding of CTD and regulatory submission formats.
  • Excellent documentation and record management skills.
  • Attention to detail and regulatory accuracy.
  • Good communication and coordination abilities.
  • Ability to track regulatory updates and changes.
  • Proficiency in MS Office documentation tools.

Educational Qualification

Bachelor of Pharmacy (BPharm)

About the Project & Industry

Regulatory affairs play a crucial role in ensuring pharmaceutical products meet safety, quality, and compliance standards before reaching global markets.

Why Join Viharsh Lifescience Private Limited?

Employees gain hands-on exposure to regulatory documentation, product approvals, and compliance management within a growing pharmaceutical organization.

How to Apply

Interested candidates should send their updated resume to: shital.regulatory@gmail.com
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