REGCURE PHARMA Hiring– Regulatory Affairs Officer
REGCURE PHARMA is hiring for the position of Regulatory Affairs Officer at its Ahmedabad location. This opportunity is open to M.Pharm freshers and candidates with 0–1 year of experience who want to build a strong career in Regulatory Affairs and Global Submissions. The role offers hands‑on exposure to CTD/eCTD dossiers, lifecycle management (LCM), ROW market submissions, and regulatory coordination within a growing pharmaceutical organization.
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🏢 About Employer
REGCURE PHARMA is a pharmaceutical organization engaged in providing regulatory affairs and compliance support across multiple global markets. The company works closely with formulation, manufacturing, quality, and clinical teams to ensure regulatory readiness and timely product approvals. Working at REGCURE PHARMA provides freshers with practical exposure to real regulatory submissions and end‑to‑end dossier management.
📊 Role Overview
- Company Name: REGCURE PHARMA
- Job Role: Regulatory Affairs Officer
- Employment Type: Full‑Time
- Experience Level: Fresher / 0–1 Year
- Educational Qualification: M.Pharm (Mandatory)
- Job Location: Ahmedabad
- Weekly Off: 2nd & 4th Saturday
- ✨ Female candidates preferred
📋 Key Responsibilities
As a Regulatory Affairs Officer, responsibilities may include:
- Preparing and compiling CTD / eCTD / ACTD dossiers for ROW markets
- Supporting Drug Master File (DMF) submissions and dossier validation activities
- Coordinating with clients to obtain, review, and organize quality, safety, and efficacy documents
- Managing Lifecycle Management (LCM) submissions such as:
- Variations
- Renewals
- PSURs
- RMPs
- PSMFs
- Providing regulatory intelligence and market‑specific regulatory guidance
- Collaborating with Formulation, QA, QC, and Manufacturing teams
- Supporting BE study protocols and clinical regulatory documentation
- Preparing deficiency responses and coordinating follow‑ups with clients and regulatory authorities
🎓 Qualification
Candidates applying for this role should meet the following criteria:
- Educational Qualification:
- M.Pharm (Mandatory)
- Experience:
- Freshers or candidates with 0–1 year of Regulatory Affairs experience
- Willingness to learn and work on global regulatory dossiers
🧠 Skills Needed
- Strong knowledge of CTD / eCTD structure
- Understanding of global regulatory requirements, especially ROW markets
- Basic computer skills (documentation and data handling)
- Good understanding of regulatory submission workflows
- Strong attention to detail and documentation accuracy
- Ability to communicate and coordinate with internal teams and clients
- Willingness to work in a regulatory‑driven, compliance‑focused environment
⭐ Job Role Insight
The Regulatory Affairs Officer role at REGCURE PHARMA is an excellent entry point for M.Pharm graduates looking to build a career in global regulatory submissions and compliance. Freshers gain hands‑on exposure to CTD/eCTD dossiers, lifecycle management activities, and client coordination. This role helps develop a strong foundation for future growth in Regulatory Affairs, Global RA Strategy, and Regulatory Operations.
🕒 Work Schedule & Benefits
- Work Location: Ahmedabad
- Working Days: As per company policy
- Weekly Off: 2nd & 4th Saturday
- Supportive professional environment with learning exposure
🎯 Who Can Apply
This opportunity is suitable for:
- M.Pharm freshers
- Candidates with 0–1 year of Regulatory Affairs experience
- Individuals interested in CTD/eCTD and ROW market submissions
- Female candidates seeking regulatory career roles in Ahmedabad
📈 Career Growth Opportunities
With training and experience, Regulatory Affairs Officers can progress into roles such as:
- Senior Regulatory Affairs Officer
- Regulatory Affairs Executive
- Global Regulatory Specialist
- Regulatory Submissions / LCM Specialist
Hands‑on exposure to global submissions significantly enhances long‑term career prospects.
🔗 How to apply
Interested candidates can apply through REGCURE PHARMA’s official hiring channel or share their resume as instructed by the company.
Important Disclaimer: This job post is shared for informational purposes only, based on publicly available job details. Candidates are advised to verify eligibility, job responsibilities, and application procedures from the official website before applying.
🔗 Explore More Opportunities
- Opportunities in Regulatory affairs
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📚 Career Guidance
If you are confuse how to preprae resume you can check it – Guide for Resume prepration
❓FAQ
1.What will be my main responsibilities?
Assisting in preparation of CTD / eCTD dossiers
Supporting lifecycle management (LCM) activities
Helping with ROW (Rest of World) market submissions
Maintaining regulatory documents and submission trackers
Coordinating with internal departments for regulatory activities
2.Is this a learning role or a support role?
It’s both. You will support live regulatory projects while simultaneously building a strong regulatory foundation.
3.Why should freshers choose REGCURE PHARMA?
Strong exposure to regulatory fundamentals
Growth‑oriented environment for early‑career professionals
Opportunity to work on real global submissions
Supportive team structure for learning and development
