Uniza Group Private Limited Life Sciences Regulatory Affairs Executive Job, Apply on Biotecnika

Life Sciences Regulatory Affairs Executive at Uniza Group Private Limited

Company Name: Uniza Group Private Limited

Job Role: Regulatory Affairs Executive

Location: Ahmedabad, Gujarat

Experience: 2–3 years of experience

Qualification / Educational Background:

• B.Pharm / M.Pharm (Pharmaceutical Sciences, Regulatory Affairs, or related discipline)

• M.Sc in Chemistry or Life Sciences (with relevant regulatory experience)
  Minimum of 2 years of experience in Regulatory Affairs in a pharmaceutical formulation company.

• Salary: 30,000–35,000 / Month

Role Summary:

A Regulatory Affairs Executive at Uniza is responsible for ensuring that pharmaceutical products comply with regulatory requirements in domestic and international markets. The role involves preparing and submitting product registration dossiers (including ACTD, CTD, and country-specific formats), maintaining regulatory documentation, coordinating with departments (R&D, QA, QC, production) to gather technical data, responding to queries from regulatory authorities, and keeping up-to-date with changes in regulatory laws and guidelines. The role often focuses on Rest of World (ROW) markets, involves tracking and managing license renewals, variations, labeling, and ensuring compliance through all stages—from development and launch to post-market surveillance.

Key Responsibilities:

• Prepare, compile, and review dossiers for product registration (CTD/eCTD formats) in domestic and international markets.

• Handle product license applications, renewals, and post-approval variations with regulatory authorities (CDSCO, State FDA, etc.).

• Ensure product labeling, packaging, and promotional materials comply with regulatory guidelines.

• Maintain regulatory documentation and track submission timelines.

• Liaise with QA, QC, R&D, and production departments for technical data required for submissions.

• Review and update product Master Files and registration documents as per latest regulatory requirements.

• Support in responding to queries from regulatory agencies in a timely and compliant manner.

• Keep abreast of current regulations, guidelines, and trends affecting pharmaceutical product registration.

• Ensure that company products meet all applicable local and international regulatory standards.

Qualifications & Skills:

• Educational Background:

  • B.Pharm / M.Pharm (Pharmaceutical Sciences, Regulatory Affairs, or related discipline)

  • M.Sc in Chemistry or Life Sciences (with relevant regulatory experience)

• Experience: Minimum of 2 years of experience in Regulatory Affairs in a pharmaceutical formulation company.

Employment Details:

• Job Types: Full-time, Permanent

• Language: English

• Salary Range: 30,000–35,000 / Month

• Location: Ahmedabad, Gujarat

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