Manager _ Medical Writing_ Regulatory Affairs - Gurgaon
1 day ago
Job description
Job Purpose
DDReg Pharma Pvt Ltd is seeking an experienced Regulatory Affairs Medical Writer 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
Authoring & Review of Regulatory Documents
Draft high-quality medical and regulatory documents in accordance with global guidelines.
Prepare complex regulatory documents such as:
— Module 2 components (Quality Overall Summary / Nonclinical Overview / Clinical Overview)
–Regulatory strategy reports
Ensure consistency, scientific accuracy, and regulatory compliance across documents.
Quality Control (QC) of Documents
Perform QC review of simple and complex documents including:
–SPC, PI, PIL, RMP
–Compiled modules for small molecules and biosimilars
–SPL, BE templates, TIF
–Aggregate reports, Expert reports
Ensure documents are delivered with high quality and within agreed timelines.
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.
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.
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
Bachelor's/Master's/PhD in Life Sciences, Pharmacy, Biotechnology, or related field.
7–10 years of experience in regulatory/medical writing.
Strong understanding of CTD format and global regulatory guidelines (ICH, FDA, EMA, CDSCO).
Hands-on experience in: –Module 2 documents –Data analysis for gap assessment –QC of regulatory deliverables
Excellent written communication, analytical skills, and attention to detail.
Proficiency in MS Office and documentation systems.
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
Related
Assistant Manager – RA- EU/UK_ Onsite
Job Title:
Assistant Manager – Regulatory Affairs (EU & UK)
Location:
Gurgaon, Haryana (India)
Experience: 4–6 YearsQualification: Master's Degree in Pharmacy (M.Pharm or equivalent) Role OverviewWe are seeking a proactive and detail-oriented Assistant Manager – Regulatory Affairs to join our Global Regulatory team.
Senior Manager-Regulatory Affairs-EU/US_Onsite
Sr
Manager-Regulatory Affairs- US/EU
Experience:
-15+ Years
Location:
Gurgaon We are looking for an experienced and accomplished Senior Manager – Regulatory Affairs (CMC) with deep expertise in US and EU regulatory frameworks.
The role will drive regulatory strategy, dossier submissions, and lifecycle management activities across these key markets, ensuring compliance and regulatory…Associate- Drug Regulatory Affairs_Canada_ (2+yrs Exp)_Onsite
Job Purpose:
We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products.
The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier preparation, particularly for Canada Markets.Key Responsibilities:
Regulatory Compliance:
In-depth knowledge of Health Canada…
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