Global Regulatory Writing Manager
On-site · Hyderabad, Telangana, India
Job Summary
Global Regulatory Writing Manager with responsibility for authoring regulatory submission documents (e.g., Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Informed Consent Forms, eCTD Module 2 Clinical Summary Documents) and conducting formal review of authored materials. With supervision, manages regulatory writing activities for product submissions (including new and supplemental drug applications/ biologics license applications) and serves as a functional area lead on project teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group). May mentor junior writers, participate in departmental initiatives, generate document timelines, and stay current with regulatory guidance. Requires advanced degree and substantial related experience; strong writing/editing skills; ability to follow SOPs and understand ICH/GCP guidance; leadership, negotiation, collaboration and project management capabilities. Location: Hyderabad, India. The role offers exposure to global regulatory strategy and cross-functional collaboration within a leading biotechnology company.
Required Qualifications
- Doctorate degree OR Master’s degree with 4 to 6 years of directly related regulatory writing experience OR Bachelor’s degree with 6 to 8 years of directly related regulatory writing experience OR Diploma with 10 to 12 years of directly related regulatory writing experience
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