Genedrift India Hiring Regulatory Affairs (0-5 Years Experience)
Are you seeking Genedrift India Careers or a Regulatory Affairs Job in Uttarakhand? Biotechnology and regulatory partner Genedrift India is actively hiring for its Regulatory Affairs team in Uttarakhand.
This dossier compilation and health authority compliance vacancy features openings across two separate levels—Senior Executive and Trainee Intern. The positions operate under a hybrid working model based in Uttarakhand. Both roles mandate a B.Pharm or M.Pharm degree. For the Trainee Intern position, entry-level freshers are eligible to apply, with candidates residing in Uttarakhand preferred. For the Senior Executive role, candidates require 2 to 5 years of experience in dossier preparation, gap analysis, and query resolutions. Selected associates will perform CMC reviews of CTD/ACTD dossiers, coordinate health authority query responses, and verify labelling drafts. To write a resume detailing your CTD formatting, dossier tracking, or health authority logs, read our guidelines on how to apply for healthcare and pharma jobs online.
📋 Job Details
| Position Details | Requirements & Mode |
|---|---|
| Senior Executive – Regulatory Affairs |
• Experience: 2–5 Years in Regulatory Affairs • Focus: CMC review, CTD/ACTD dossiers, gap analysis, health authority query management • Work Mode: Hybrid (Uttarakhand) |
| Trainee Intern – Regulatory Affairs |
• Experience: Freshers / Entry-Level (0 Years) • Preference: Candidates from Uttarakhand preferred • Focus: Document coordination, SOP logs, database entry, translation reviews |
| Qualification (Both Roles) | B.Pharm / M.Pharm (Mandatory qualification) |
| Estimated Salary |
• Trainee Intern: ₹2.0 – ₹3.0 LPA • Senior Executive: ₹4.5 – ₹7.5 LPA |
💼 Key Responsibilities
1. Senior Executive – Regulatory Affairs:
- Dossier CMC Review: Conduct Chemical, Manufacturing, and Controls (CMC) audits of CTD/ACTD dossiers, SmPCs, labelling documents, and patient leaflets.
- Gap Analysis: Prepare and verify gap analysis records for global drug dossiers to ensure compliance before submissions.
- HA Queries Management: Oversee health authority query reviews, compile deficiencies responses, and organize final submissions.
- Pre-Submission Coordination: Support regulatory teams during pre-submission preparation and agency review cycles.
2. Trainee Intern – Regulatory Affairs:
- Team Coordination: Interface with analytical development and manufacturing units to request raw technical documentation.
- SOP Compliance: Learn and verify document version histories and system parameters within the document management platform.
- Timeline Tracking: Maintain internal database logs tracking project milestones and dossier submission dates.
- Document Support: Assist senior officers with dossier translations, formatting reviews, and printing preparations.
To learn how regulatory affairs specialists and CMC dossier reviewers salaries compare to conventional pharmacovigilance drug safety associate and clinical programming tracks, read our report on Pharmacovigilance Salary: India vs USA.
🎓 Required Qualifications & Skills
- Academic: Bachelor of Pharmacy (B.Pharm) or Master of Pharmacy (M.Pharm) degree. (Essential credential for both intern and executive vacancies).
- Regulatory Knowledge: Deep understanding of CTD/ACTD formats, product label requirements, and global regulatory rules.
- Communication: Good written and verbal English communication to write health authority answers.
- General Skills: Proficiency in Microsoft Office (specifically Excel and Word for formatting templates) and internet research.
For pharmacy graduates evaluating regulatory dossier publishing compared to conventional laboratory quality control or chemical formulation careers, read our analysis on B.Pharm Careers after Graduation: India vs USA.
🎁 Why Join Genedrift India?
- Obtain robust technical training in compiling Common Technical Document (CTD) structures.
- Build global regulatory experience tracking health authority queries.
- Embrace a flexible hybrid scheduling model.
- Competitive salaries and rapid career progression in the regulatory compliance sector.
To review your basic knowledge of patient registries, clinical parameters, and GCP guidelines before your screening assessments, try our interactive Clinical Trial Assistant (CTA) Quiz.
💡 Regulatory Analyst vs Healthcare IT
Genedrift Regulatory Affairs Officers draft dossiers, audit CMC sections, and coordinate labelling compliance, whereas Healthcare IT professionals support software deployments. To explore these differences, read our comparison on Healthcare IT vs Clinical Healthcare.
📝 Resume Tips for Genedrift Candidates
- Highlight Dossier Formats: Explicitly mention your familiarity with ICH CTD modules (Module 1 to Module 5) or ACTD styles.
- Specify CMC Skills: List previous projects analyzing Chemical Manufacturing and Control records if applying for the senior executive role.
- Show Local Preference: If applying for the intern role and living in Uttarakhand, state your address details in the CV header.
💬 Genedrift Regulatory Affairs Interview Questions
- Q1. What is the difference between a CTD and an ACTD dossier?
Answer Guidance: CTD (Common Technical Document) is the harmonized format used across ICH regions (US, Europe, Japan). ACTD (ASEAN Common Technical Document) is a simplified dossier structure structured specifically for ASEAN countries, featuring differences in stability data and layout. - Q2. How do you define Module 3 of the Common Technical Document?
Answer Guidance: Module 3 contains Quality information, detailing the chemical, pharmaceutical, and biological parameters of both the drug substance (active pharmaceutical ingredient) and the drug product (final formulation). - Q3. Explain the term 'Gap Analysis' in regulatory dossier review.
Answer Guidance: Gap Analysis is the process of reviewing an existing dossier against the latest guidelines of a target health authority to identify missing stability reports, manufacturing logs, or data discrepancies before submission.
📖 How to Apply?
Before submitting your application, please read the step-by-step guidance on how to navigate the registration portal, fill out required forms, and format your application profile:
📄 Resume Builder Service
Want to build a professional ATS-friendly resume tailored for Regulatory Affairs, Dossier Management, or QA roles? Message us directly on our LinkedIn Company Page with the phrase "I want Resume Builder Service", and our expert team will connect with you:
📲 Message Us on LinkedIn🚀 Direct Application Links
If you are ready with your resume and profile documents, submit your application directly via the official recruitment boards:
Apply Online – Genedrift Zoho Form❓ Frequently Asked Questions
Q. Is a pharmacy degree mandatory for the Genedrift Trainee Intern role?
Yes, both positions (Senior Executive & Trainee Intern) mandate a B.Pharm or M.Pharm degree qualification.
Q. Are these positions hybrid or fully remote?
These positions are hybrid roles based in Uttarakhand, combining in-office work days and remote work flexibility.
Q. What is the preferred residency for the Intern role?
Candidates residing in Uttarakhand are preferred for the Trainee Intern opening.
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