Exemed Pharmaceuticals Hiring Regulatory Affairs Executive – Domestic (DCGI)

Regulatory Affairs Executive Jobs for B.Pharm/M.Pharm – Exemed Pharmaceuticals, Vadodara

Apply for Regulatory Affairs Executive – Domestic (DCGI) at Exemed Pharmaceuticals, Vadodara. Qualification: B.Pharm/M.Pharm, 2–4 years’ experience.

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Join Exemed Pharmaceuticals as a Regulatory Affairs Executive (Domestic – DCGI)

If you hold a B.Pharm or M.Pharm degree and have 2–4 years of experience in Drug Regulatory Affairs, this is your opportunity to work with Exemed Pharmaceuticals, a trusted name in the pharmaceutical industry. This role is based at our Corporate Office in Vadodara and focuses on the Domestic (DCGI) Market.

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About Exemed Pharmaceuticals

Exemed Pharmaceuticals is a reputed pharmaceutical company known for its quality manufacturing, innovation, and compliance with stringent regulatory standards. We are committed to providing safe and effective medicines that meet both domestic and international quality requirements.

Website: www.exemedpharma.com

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Role Overview

As a Regulatory Affairs Executive, you will be responsible for managing the preparation, submission, and follow-up of regulatory dossiers and applications to ensure timely approvals from the Drug Controller General of India (DCGI).

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Key Responsibilities

Regulatory Submissions & Approvals

• Work on SUGAM portal and CDSCO website for regulatory submissions.
• File applications for Manufacturing & Marketing (CT21/CT-18) for IND, New Drugs, Subsequent New Drugs, and Fixed Dose Combinations (FDCs).
• Apply for clinical trial permissions (CT-05/CT-04, CT-10/CT-12/CT-13).
• Handle applications for Import Licenses (CT-16, Form 12, Form 08).
• Submit documents to Indian Pharmacopoeia Commission (IPC).
• Prepare Form 29 applications.

Documentation & Data Preparation

• Prepare presentations for Subject Expert Committee (SEC) meetings.
• Maintain product lifecycle and management records.
• Compile Module 4 & 5 Nonclinical & Clinical data.
• Develop Pack Inserts (PI), Patient Information Leaflets (PIL), and Summary of Product Characteristics (SPC).
• Conduct literature searches (Nonclinical, Clinical, Formulation).
• Prepare product monographs and various scientific rationales.

Compliance & Guidelines

• Follow BABE Guidelines, Clinical Trial Phase III protocols, and animal toxicology standards.

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Desired Candidate Profile

• Qualification: B.Pharm / M.Pharm
• Experience: 2–4 years in Regulatory Affairs (Domestic Market)
• Strong understanding of DCGI regulations and approval processes.
• Excellent documentation, communication, and coordination skills.

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Work Location & Salary

• Location: Vadodara (Corporate Office)
• Salary: Open and negotiable, based on experience and skills.

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Why Join Exemed Pharmaceuticals?

• Opportunity to work in a dynamic, growth-oriented pharma company.
• Exposure to end-to-end regulatory processes.
• Competitive salary with growth prospects.
• Work in a collaborative environment with industry experts.

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How to Apply

Interested candidates can send their updated resumes to: recruitment@exemedpharma.com

Ensure you attach all relevant documents, including your CV, experience certificates, and qualification details.

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Quick Reference Table

Company Name	Current Vacancies & Designation	Required Education	Experience Required
Exemed Pharmaceuticals	Regulatory Affairs Executive – Domestic (DCGI)	B.Pharm / M.Pharm	2–4 Years