Medical Writer - Regulatory

Why This Role Matters
The Medical Writer – Regulatory is responsible for preparing high-quality regulatory documents that support drug development and submissions in Europe. This role ensures that clinical and nonclinical data are presented clearly, accurately, and in compliance with ICH, EMA, and other regulatory requirements. By contributing to Module 2 overviews, clinical study reports, safety updates, and labeling documents, the Medical Writer plays a critical role in facilitating approvals and enabling patient access to safe and effective medicines.

Job Description
The Medical Writer – Regulatory will produce, review, and maintain high-quality regulatory documents including CTD modules, clinical study reports, safety variations, and product labeling documents. The role involves collaborating with cross-functional teams such as clinical development, pharmacovigilance, regulatory affairs, and medical affairs to ensure scientific accuracy, regulatory compliance, and alignment with development strategies. The Medical Writer will also support responses to regulatory queries, clinical deficiencies, and provide input on clinical development strategies.

Key Features Of The Role
• Writing high-quality CTD modules, including nonclinical and clinical overviews and summaries (Module 2.5, 2.4, 2.7) as per EU submission requirements
• Responding to clinical deficiencies raised by regulatory authorities
• Assisting with drug development strategies and regulatory planning
• Updating SmPC, Patient Information Leaflets, CCDS, and other labeling documents
• Preparing clinical study reports, study designs, and synopses
• Reviewing study reports, published papers, and literature searches for regulatory evaluation
• Conducting Rx to OTC evaluations as required
• Preparing PSURs, PADERs, RMPs, and other safety-related submissions

Responsibilities
• Author and review CTD modules including nonclinical overview, clinical overview, and summaries
• Ensure scientific accuracy, clarity, and adherence to ICH and EMA guidelines
• Contribute to the preparation of safety variations, labeling updates, and regulatory documentation
• Conduct literature searches and evaluate published data in the context of regulatory requirements
• Support clinical development strategy by reviewing study designs, protocols, and clinical study reports
• Assist in responses to regulatory queries, clinical deficiencies, and submission requirements
• Collaborate with cross-functional teams including pharmacovigilance, regulatory affairs, clinical development, and medical affairs
• Ensure timely delivery of high-quality documents to meet submission timelines
• Support preparation of periodic safety reports such as PSURs, PADERs, and Risk Management Plans
• Evaluate clinical pharmacology data for generics, hybrid, and new drug applications

Required Qualifications

Educational Requirements
• MBBS in Medicine, M.Pharma in Pharmacy, Medical MS/MD in Pharmacology, Ph.D. or Doctorate in Pharmacy
• Specialization in Pharmacology is desirable

Experience And Skills
• Experience in medical writing for regulatory submissions in Europe
• Proficiency in authoring nonclinical overviews, clinical overviews, PSURs, and Module 2 CTD submissions
• Understanding of Generic, Hybrid, and New drug applications
• Knowledge of clinical study design, protocols, and clinical pharmacology
• Strong scientific accuracy and attention to detail
• Excellent written and verbal communication skills
• Effective time management and ability to handle multiple projects
• Familiarity with ICH guidelines, EMA labeling, DCP, and regulatory submission processes

Salary Insights
• Compensation as per company norms, aligned with experience and industry standards
• Performance-based incentives and opportunities for career growth
• Benefits include professional development, training, and exposure to European regulatory submissions

Company Overview
The organization is a global pharmaceutical and biotechnology service provider focused on regulatory support, drug development, and medical writing services. It collaborates with pharmaceutical companies worldwide to deliver high-quality regulatory documentation, ensuring scientific accuracy, compliance, and timely submissions. The company emphasizes a collaborative culture, professional growth, and continuous learning.

FAQs
Q: What types of documents will I work on?
A: The role involves CTD modules, clinical study reports, PSURs, PADERs, safety variations, and labeling documents for EU submissions.

Q: Will I be working independently?
A: The Medical Writer collaborates closely with cross-functional teams but also has significant responsibility for independently authoring and reviewing documents.

Q: Is training provided?
A: Yes, training and mentoring are provided for regulatory writing standards, EMA/ICH guidelines, and clinical documentation.

Q: Will I need experience in pharmacology?
A: Experience in clinical pharmacology and medical writing is required; specialization in pharmacology is preferred.

Application Tips
• Highlight experience in medical writing for EU regulatory submissions
• Emphasize skills in CTD modules, clinical overviews, nonclinical overviews, PSURs, and safety reporting
• Demonstrate knowledge of generic, hybrid, and new drug applications
• Showcase ability to manage multiple projects and meet strict submission timelines
• Include examples of high-quality regulatory documents authored for European submissions