Role & responsibilities

DRA department-Deputy Manager/Manager for Europe Market.

Total Experience : 8-15 Years

CTC budget : Negotiable

Location : Koparkhairane, Navi Mumbai

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 EMA 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.

Interested applicants share cv on [email protected]

📌 Dy.Manager / Manager Regulatory Affairs EU Market- Pharma- Navi Mumbai
🏢 Hector and Streak Consulting
📍 Navi Mumbai