Support the drafting of basic medical and regulatory documents such as Prescribing Information (PI), biowaiver justifications, clinical and non-clinical overviews, Structured Product Labeling (SPL), bioequivalence (BE) templates, Technical Information Files (TIF), and supporting regulatory documents under senior guidance.
Assist in reviewing source documents, clinical and non-clinical study reports, and published scientific literature to extract relevant information for regulatory submissions.
Perform preliminary quality checks on regulatory and medical writing documents to ensure accuracy, formatting consistency, and alignment with regulatory guidelines.
Support gap analysis activities for small molecules and biosimilars by identifying missing or unclear information in clinical and non-clinical datasets.
Assist in preparing draft responses to regulatory or client queries, including updating documents based on feedback and review comments.
Participate in literature searches and reference management to support medical and regulatory documentation.
Learn and apply global regulatory guidelines and document standards relevant to medical writing.
Support project tracking activities by maintaining documentation, version control, and work trackers.
Communicate progress and challenges effectively with team members and supervisors.
Demonstrate a proactive learning attitude, attention to detail, and willingness to adapt to evolving regulatory requirements.
Education
Master’s degree in pharmacology (M.Pharm – Pharmacology) Only.
Knowledge, Skills and Abilities
Proficiency in Microsoft Word, Excel, and PowerPoint
Excellent written and spoken English
Result-oriented and deadline-driven approach
Other requirements
As may be required from time to time – the incumbent may be required to working slots catering to different time zones
Location
Gurgaon, Haryana (INDIA)
Related
Job Features
Job Category
Regulatory Affairs
📌 Regulatory_ Medical Writing (Gurugram)
🏢 DDReg Pharma
📍 Gurugram
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