RA-CMC Associate

We are seeking a detail-oriented professional to support end-to-end submissions for global markets.

This role involves preparing Variation documents and/or evaluating post-approval CMC changes in compliance with global regulatory requirements. You will contribute to Lifecycle Management activities by helping to compile and review CTD dossier modules. Your tasks may include compiling initial dossiers (Modules 2 & 3) for major markets including the US, EU, SA, WHO, ANZ, and other countries. You will provide regulatory strategies and conduct evaluations of post-approval CMC changes considering ICH and country-specific guidelines.

Responsibilities:

• Variation Documents Preparation: Prepare Variation documents and evaluate post-approval CMC changes in compliance with global regulatory requirements.
• Lifecycle Management Activities: Contribute to Lifecycle Management activities by helping to compile and review CTD dossier modules.
• Initial Dossier Compilation: Compile initial dossiers (Modules 2 & 3) for major markets including the US, EU, SA, WHO, ANZ, and other countries.
• Regulatory Strategies Evaluation: Provide regulatory strategies and conduct evaluations of post-approval CMC changes considering ICH and country-specific guidelines.
• Variation/Submission Management: Manage compilation and submission of variations/supplements for major markets worldwide.
• Query/Workflow Management: Utilize Veeva Vault RIM to track queries and manage submission workflows.

Experience Requirement:

• Minimum Experience: At least 3 years of experience in managing Initial submissions, Variations, and full LCM deliverables for the global market.
• Veeva Expertise: Hands-on experience with Veeva Vault RIM is essential.
• ICH/Guidelines Knowledge: Proficient in ICH guidelines and regulatory guidelines for major markets worldwide.
• Initial Dossier Skills: Hands-on experience in initial dossier compilation for major markets (Module 2 & 3).
• Regulatory Strategies Skill: Experienced in providing Regulatory strategies/Evaluation by performing assessment of post approval CMC Changes considering global regulatory requirements.

Our ideal candidate has strong analytical skills, attention to detail, and excellent communication skills. Experience working with global regulatory requirements and ICH guidelines is highly desirable. Familiarity with Veeva Vault RIM and ability to work effectively in a team environment are essential.

This is an exciting opportunity to work on complex projects and develop your skills as a RA-CMC Associate. If you have a passion for regulatory affairs and want to make a meaningful contribution to our organization, we encourage you to apply.