Assistant Manager - DRA

NA; Navi Mumbai, Mumbai; On-site; INR 1,200,000 - 1,600,000; Full time

Job summary

Regulatory affairs professional sought for Europe market exposure and team leadership in Navi Mumbai. The role requires deep regulatory knowledge and hands-on experience with CTD submissions, EMA procedures, and cross-functional dossier management.

Responsibilities include coordinating complex regulatory submissions, ensuring compliance with EU guidelines, and guiding technical writing and project timelines to achieve timely market authorisation across pharmaceuticals, biologics and medical

Qualifications

• Extensive knowledge of EU regulations, directives and guidelines governing pharmaceuticals, biologics and medical devices.

Responsibilities

• Exposure of Europe market & team handling is mandatory.
• Deep Regulatory Understanding: - Extensive knowledge of EU Regulations, directives and guideline governing pharmaceuticals, biologics and medical devices.
• Expertise in CTD Format: - Mastery of the common technical document (CTD) format with proficiency in compiling and organising regulatory submission across all modules.
• EMA Procedure mastery: - In depth understanding of EMA procedures, including centralised, decentralised and mutual recognition, for marketing authorisation applications.
• Technical Writing proficiency: - Advanced skills in drafting, editing, reviewing regulatory documents to ensure compliance and clarity.
• Comprehensive Guidance Awareness-: Awareness of a wide range of EMA guideline, regulations and best practice relevant to dossier compilation.
• Advance project management skills for coordinating complex dossier, compilation projects, managing timelines and overseeing cross functional teams.
• Expertise in Regulatory Submission tools.

Job description

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.