Assistant Manager - DRA

Role & responsibilities

1. Exposure of Europe market & team handling is mandatory.

2. Deep Regulatory Understanding: - Extensive knowledge of EU Regulations, directives and guideline governing pharmaceuticals, biologics and medical devices.

3. Expertise in CTD Format: - Mastery of the common technical document (CTD) format with proficiency in compiling and organising regulatory submission across all modules.

4. EMA Procedure mastery: - In depth understanding of E MA procedures, including centralised, decentralised and mutual recognition, for marketing authorisation applications.

5. Technical Writing proficiency: - Advanced skills in drafting, editing, reviewing regulatory documents to ensure compliance and clarity.

6. Comprehensive Guidance Awareness-: Awareness of a wide range of EMA guideline, regulations and best practice relevant to dossier compilation.

7. Advance project management skills for coordinating complex dossier, compilation projects, managing timelines and overseeing cross functional teams.

8. Expertise in Regulatory Submission tools.