S Kant Healthcare Hiring Regulatory Affairs Executive
- M.Pharm Regulatory Affairs Executive | S Kant Healthcare | Vapi
- Company Overview
- Job Role & Responsibilities
- Eligibility / Qualifications
- Location & Salary
- Application Process
- Why Join S Kant Healthcare Ltd.?
- FAQs
- Job Summary Table
M.Pharm Regulatory Affairs Executive | S Kant Healthcare | Vapi
Apply for Regulatory Affairs Executive at S Kant Healthcare Ltd., Vapi. M.Pharm, 2–3 yrs experience.
S Kant Healthcare Ltd., a reputed name in the Indian pharmaceutical industry, is hiring Regulatory Affairs Executives for its Vapi, Gujarat facility. This opportunity is perfect for M.Pharm professionals with 2–3 years of experience seeking to build a career in regulatory documentation, dossier preparation, and international market compliance.
Company Overview
S Kant Healthcare Ltd., headquartered in Mumbai with advanced manufacturing operations in Vapi, is one of India’s fast-growing pharmaceutical and healthcare organizations. The company is engaged in research, development, manufacturing, and global distribution of high-quality active pharmaceutical ingredients (APIs) and finished dosage forms.
With a strong commitment to innovation and global healthcare excellence, S Kant operates under strict cGMP and WHO-GMP guidelines, ensuring compliance with the highest international regulatory standards. The company exports to multiple countries, delivering value-driven products across therapeutic areas.
Job Role & Responsibilities
Position: Regulatory Affairs Executive
Department: Regulatory Affairs
Qualification: M.Pharm
Experience: 2–3 Years
Location: Vapi, Gujarat
Key Responsibilities:
- Prepare, compile, and review dossiers as per CTD/ACTD/eCTD format and regulatory authority requirements.
- Coordinate with Production, QA, QC, and R&D departments for technical documentation and data collection.
- Prepare, validate, and maintain product registration files for submission to global regulatory authorities.
- Support the submission of applications for new product registrations, renewals, and variations.
- Assist in responding to regulatory queries, deficiency letters, and audit findings.
- Maintain up-to-date knowledge of international regulatory guidelines (ICH, WHO, EU, GCC, ASEAN).
- Ensure compliance with Good Documentation Practices (GDP) and company SOPs.
- Coordinate with external stakeholders for dossier preparation, translations, and follow-ups with local agents.
Eligibility / Qualifications
Educational Qualification:
- M.Pharm (Pharmaceutical Regulatory Affairs / Pharmaceutics / Pharmaceutical Analysis / Quality Assurance).
Experience:
- 2–3 years of experience in Regulatory Affairs within a pharmaceutical formulation or API manufacturing setup.
Relevant Courses (comma-separated): Regulatory Affairs, Pharmaceutical Quality Systems, CTD/ACTD Dossier Preparation, Good Regulatory Practices, ICH Guidelines, Technical Writing in Pharma.
Desired Skills:
- Strong knowledge of CTD/ACTD dossier compilation and review.
- Familiarity with international registration procedures for regulated and semi-regulated markets.
- Excellent communication and documentation skills.
- Analytical mindset, accuracy, and detail orientation.
- Proficiency in MS Office, data management tools, and document control systems.
Location & Salary
Location: Vapi, Gujarat
Company: S Kant Healthcare Ltd.
Experience Level: 2–3 Years
Salary: As per industry standards and candidate experience
Employment Type: Full-Time
Application Process
Interested candidates can apply by sending their updated CVs to:
Email: hr@skant.com
Please mention “Application for Regulatory Affairs Executive – Vapi” in the subject line for faster processing.
Only shortlisted candidates will be contacted for the next stage of the recruitment process.
Why Join S Kant Healthcare Ltd.?
- Work with a globally recognized pharmaceutical manufacturer with expanding global market reach.
- Exposure to international regulatory submissions and compliance frameworks.
- Collaborative work environment with career advancement opportunities in regulatory and quality domains.
- Opportunity to contribute to global drug registration and market authorization processes.
- Part of a team that ensures safe, effective, and quality medicines reach patients worldwide.
FAQs
1. What qualifications are required for this position?
Candidates must hold an M.Pharm degree in Regulatory Affairs, Pharmaceutics, or related fields with 2–3 years of experience.
2. What does the role involve?
The role focuses on dossier preparation, coordination with production and QA teams, regulatory submissions, and responding to queries.
3. Is experience in international submissions mandatory?
Yes, prior experience in regulatory submissions for ROW or regulated markets is preferred.
4. How do I apply?
Email your updated resume to hr@skant.com with the subject line “Application for Regulatory Affairs Executive – Vapi.”
5. What type of company is S Kant Healthcare?
S Kant Healthcare is a reputed Indian pharmaceutical manufacturer serving both domestic and international markets, compliant with WHO-GMP and cGMP standards.
Job Summary Table
| Category | Details |
|---|---|
| Company | S Kant Healthcare Ltd. |
| Vacancies | Regulatory Affairs Executive |
| Required Education | M.Pharm |
| Experience | 2–3 Years |
| Location | Vapi, Gujarat |
| hr@skant.com | |
| Department | Regulatory Affairs |
| Salary | As per industry standards |
To apply for this job email your details to hr@skant.com
