Job Title: Lead – Regulatory Writing
Location: Bangalore, Karnataka, India
Experience: 4 to 6 years
Education: MBBS, PhD, MDS, BDS, MPharm, or PharmD
Work Mode: On-site
Preferred Compensation: Not specified in the description
Job Summary:
We are seeking a highly skilled Lead – Regulatory Writing professional with 4–6 years of experience in authoring clinical and regulatory documents supporting global filings. This role is ideal for candidates with in-depth knowledge of CTD modules, regulatory guidelines, and clinical document preparation. As a lead writer, you will manage document development, mentor junior writers, and collaborate with cross-functional teams across therapeutic areas.
Key Responsibilities:
Prepare and review clinical study reports (CSRs), protocols, IBs, submission summaries, and related documents.
Apply lean authoring and structured content principles in all deliverables.
Coordinate document review, quality control, and finalization under tight deadlines.
Lead document kick-off meetings and ensure content alignment and consistency.
Develop and maintain project-specific timelines and plans.
Coach and mentor junior writers and support onboarding activities.
Conduct literature reviews and stay updated with global regulatory standards.
Ensure document quality aligns with internal and sponsor-specific standards.
Collaborate with cross-functional stakeholders to interpret data and address feedback.
Required Skills & Qualifications:
4–6 years’ experience in clinical and regulatory medical writing.
Expertise with CTD Module 2 (2.3, 2.4, 2.5, 2.7) and Module 5.
Strong writing, editing, and communication skills.
Proven ability to manage document delivery timelines and team coordination.
In-depth knowledge of ICH, GVP, EU, and FDA regulatory standards.
Experience across therapeutic areas and ability to write without direct supervision.
Proficient in Microsoft Word and document management systems.
Comfortable using document automation tools and templates.
Ability to build regulatory arguments using logic and therapeutic knowledge.
Perks & Benefits:
Work with a global regulatory writing team
Opportunity to contribute to international clinical submissions
Professional development and mentorship opportunities
Collaborative and science-driven work culture
Exposure to cross-functional clinical and regulatory processes
Company Description:
Join a globally recognized pharmaceutical and life sciences leader known for advancing healthcare innovations through rigorous research, regulatory excellence, and cross-functional collaboration. Our clinical and regulatory writing teams play a vital role in global drug submissions and product development.
Work Mode:
On-site – Bangalore, Karnataka
Call-to-Action:
If you're a seasoned regulatory writer ready to take on a leadership role, apply now to join a dynamic team shaping global healthcare submissions.
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