Haryana Regulatory medical writer Jobs – 10 Open Jobs Today

Regulatory Medical Writer
GoStravvy —Gurugram, Haryana
- ₹66,000 - ₹12,50,000 a month
- Full-time
- Doctoral degree
- Data analysis skills
- Microsoft Office
- Health insurance
- Paid time off
Quick apply
Medical Writer
Stryker —Gurugram, Haryana
- Full-time
- Master's degree
- Bachelor's degree
- Health insurance
10d
Medical Writers
medONE Pharma Solutions India —Gurugram, Haryana
- Medicine
- Master's degree
- Bachelor's degree
- Work from home
Medical Writer II (MLR Reviewer +Veeva)
サイネオス・ヘルス —Gurugram, Haryana
- Travel
Manager _ Medical Writing_ Regulatory Affairs
DDReg Pharma —Gurugram, Haryana
- Full-time
- Doctoral degree
- Data analysis skills
- Microsoft Office
Medical Writer -Research
WNS Global Services —Gurugram, Haryana
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Medicine
Quick apply
1d
Senior Medical Writer (Medical Information Writing)
サイネオス・ヘルス —Gurugram, Haryana
- Databases
- Travel
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Aditya Birla Group —Haryana
Customer Service Executive - Gurgaon
Aditya Birla Group —Haryana
3d
Design Manager
Gensler —Gurugram, Haryana
- Full-time
- AutoCAD
- Hospitality
- Microsoft Office
- Health insurance

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Regulatory Medical Writer
GoStravvy —Gurugram, Haryana
3-7 years of experience in regulatory/medical writing. We are seeking an experienced Regulatory Affairs Medical Writer (Module 4 & 5 ) of CTD , responsible for…
₹66,000 - ₹12,50,000 a month
Quick apply
Medical Writers
medONE Pharma Solutions India —Gurugram, Haryana
Production and publication of peer-reviewed scientific papers and presentations explaining the results of clinical studies.

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Regulatory Medical Writer

GoStravvy
Gurugram, Haryana

Quick apply

Job details

Permanent | Full-time
₹66,000 - ₹12,50,000 a month

Benefits

Provident Fund
Health insurance
Paid time off
Food provided
Paid sick time

Qualifications

Doctoral degree
Data analysis skills
Biotechnology
Microsoft Office
Master's degree
Analysis skills
Bachelor's degree
Quality control
EMR systems
B.E.
Document management systems
Communication skills

Full job description

We are seeking an experienced Regulatory Affairs Medical Writer (Module 4 & 5 ) of CTD , responsible for drafting, reviewing, and ensuring the accuracy of scientific and regulatory documents in alignment with global standards. The role involves preparation of complex CTD modules, quality control of submissions, gap analysis, and support in responding to regulatory queries. The ideal candidate will collaborate cross-functionally and support team development and process improvement.Key Responsibilities:1) Authoring & Review of Regulatory Documents

Draft high-quality medical and regulatory documents in accordance with global guidelines.
Prepare complex regulatory documents such as:

o Module 2 components (Quality Overall Summary / Nonclinical Overview / Clinical Overview) o Regulatory strategy reports

Ensure consistency, scientific accuracy, and regulatory compliance across documents.

2) Quality Control (QC) of Documents

Perform QC review of simple and complex documents including:

o SPC, PI, PIL, RMP o Compiled modules for small molecules and biosimilars o SPL, BE templates, TIF o Aggregate reports, Expert reports

Ensure documents are delivered with high quality and within agreed timelines.

3) Gap Analysis

Perform gap assessment for small molecules and biosimilar products.
Evaluate non-clinical and clinical data provided by clients to identify deficiencies affecting product submission/approval.
Draft structured gap reports/sheets and propose corrective actions.

4) Query Response & Literature Support

Support regulatory query responses by evaluating existing documents and addressing authority/client questions.
Conduct literature searches to update documentation and prepare query response reports as required.
Work with cross-functional teams to ensure clarity and customer satisfaction.

5) Mentoring & Training

Support resolution of technical/medical doubts raised by team members.
Provide on-the-job training and guidance to direct reportees.
Identify training needs for self and team on a quarterly basis.

Key Skills & Requirements:

Bachelors/Masters/PhD in Life Sciences, Pharmacy, Biotechnology, or related field.
3-7 years of experience in regulatory/medical writing.
Strong understanding of CTD format and global regulatory guidelines (ICH, FDA, EMA, CDSCO).
Hands-on experience in:

oModule 2 documents o Data analysis for gap assessment o QC of regulatory deliverables

Excellent written communication, analytical skills, and attention to detail.
Proficiency in MS Office and documentation systems.

Preferred Skills

Experience with eCTD compilation/submissions.
Experience with biosimilars & small molecules.
Familiarity with regulatory query management and health authority interactions.
Ability to interpret clinical/non-clinical data and scientific literature.
Why Join Us
Opportunity to contribute to key regulatory submissions
Exposure to global health authority expectations
Skill development and continuous learning environment
Collaborative work culture

Job Types: Full-time, Permanent

Pay: ₹66,000.00 - ₹1,250,000.00 per month

Benefits:

Food provided
Health insurance
Paid sick time
Paid time off
Provident Fund

Work Location: In person

Quick apply

Refine Your Search

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