8 ش عبد الحكيم الجارحي ارض الجولف مصر الجديدة- القاهرة

Prepare, write, and review regulatory submissions in CTD format (Modules 1, 2, 3).

Draft medical and regulatory documents including clinical overviews, summaries, briefing documents, package inserts, variations, and responses to health authorities.

Collaborate with cross-functional teams (Clinical, Quality, Pharmacovigilance, Marketing) to collect and compile scientific data.

Stay updated on international regulatory guidelines (FDA, EMA, EDA, ICH).

Develop and maintain Target Product Profile (TPP) and ensure alignment with the clinical development strategy.

Support onco-dossier preparation and manage the complexities of oncology data, including Kaplan-Meier plots, efficacy endpoints, and AESIs.

Participate in the planning and execution of regulatory strategies for new product approvals and life-cycle management.

Ensure clarity, consistency, and compliance in all written materials.

Assist in the preparation of Medical Content for educational and promotional materials when required.