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Are you the one we are looking for?
Inviting applications for the role of Lead Consultant Regulatory Affairs, Consumer CMC for Global market !
GRA complete spectrum of regulatory and compliance services include compliance evaluation, critical issue remediation and resolution, risk assessment analysis, supporting system design and deployment, gap analysis, pharmacovigilance and Publishing. Driving transformation and improving regulatory compliance with domain expertise and digital technology.
Responsibilities
In this role, you will be responsible for:
1. Responsible for implementing CMC regulatory strategies for assigned consumer products in accordance with global regulations, guidance and defined regulatory strategies.
2. Responsible for the writing of CMC quality documents for the dossier and/or the entire module 3 from raw data.
3. Review and evaluation of existing quality documentation and assessment of required updates during Project Renewals.
4. Preparation of Quality Overall Summaries (QOS) for drug product and drug substance.
5. Compilation of dossiers for launch applications for marketing authorization and new drug applications in Global markets.
6. Submission of relevant sections in Annual Reports for US Market.
7. Preparing RA expert response for deficiency letters from various regulatory authorities;
8. Assessment of registration documentation for consumer products as per the current Health Authority requirements.
9. Knowledge of review and assessment of manufacturing, analytical, validation and stability documents.
10. Post-approval submission knowledge for EU markets
Qualifications we seek in you!
Minimum qualifications
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