MASUU Global Careers – Hiring Medical Writer – Regulatory Writing

MASUU Global, a leading company in pharma regulatory, quality services, and software solutions, is expanding its team in Hyderabad. We are hiring skilled professionals for Medical Writing – Pharma Safety & Regulatory Documents. If you are passionate about regulatory submissions, compliance, and scientific writing, this is your opportunity to work with a global leader.

Job Details

• Position: Medical Writer – Regulatory Writing
• Vacancies: 2
• Type: Full-Time (Immediate Joiners / <30 Days Notice)
• Location: Hyderabad – Miyapur (Onsite, No Work From Home)

Experience Levels

• Managerial Role: 8–10 Years
• Executive Role: 2–4 Years

Key Responsibilities

• Author, review, and manage clinical and regulatory documents supporting global regulatory submissions.
• Contribute to regulatory interactions (Type A, B, C meetings).
• Ensure alignment with ICH and global regulatory requirements.
• Collaborate with cross-functional teams: PV, Clinical, Regulatory, Safety, and Legal.
• Mentor junior writers and conduct peer reviews.
• Support regulatory writing strategies and deliverables.

Prepare and finalize critical documents including:

• CTD Modules 2.5 & 2.7
• Risk Management Plans (RMP)
• Initial Paediatric Study Plans (IPSP)
• Study Protocols & Investigator Brochures (IB)
• Pre-IND / IND documents
• IMPDs & Scientific Advice Packages
• PSURs & PBRERs

Ideal Candidate Profile

• Strong knowledge of regulatory writing standards and compliance.
• Ability to handle multiple projects within strict timelines.
• Excellent communication and teamwork skills.
• Proven expertise in authoring documents for regulatory submissions.

How to Apply

Interested candidates can send their CVs in the specified format:
📧 Email: hiring@masuuglobal.com
📱 Call / WhatsApp: 9154979318
🔗 LinkedIn (HR Contact): Harika Challagurugula
🌐 Visit: www.masuuglobal.com

Subject Line: CV for Medical Writer

Why Join MASUU Global?

• Opportunity to work with leading experts in pharma regulatory writing.
• Be part of an innovative, fast-growing company with global exposure.
• Contribute to critical regulatory submissions impacting international markets.
• Build your career in a supportive and collaborative environment.

🚀 Join MASUU Global and make a difference in the future of regulatory science and global healthcare.