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Under the direction of the line manager the SRS specialist is responsible for providing Submission Ready Standard Application during the preparation of high quality regulatory submissions and a wide range of supporting documentation across the drug development lifecycle including pipeline programs (IMPD/CTA/IND), Marketing Applications (NDA, MAA, BLA, JNDA) and Agency request for information, Briefing Books, Post- Approval changes or compliance updates across all global franchises.
In addition the SRS Specialist will also be expected to drive, support and contribute to broader improvement initiatives that contribute to Clients overall success.
Describe the essential daily job functions and include % of time spent on each.
% of Time Job Function and Description
90% SRS Application
• Undertake document formatting to ensure consistency with company and health authority submission ready standards.
• Review documents for submission-readiness and conformity company and health authority guidelines.
• Undertake the submission build activities for both paper and electronic regulatory submissions, ensuring submissions are built with submission-ready documents, creating intra-document links, performing quality check and validating compiled submissions, and finalizing submission by required dispatch date.
• Support authors with loading documents into EDMS and concatenation as required
• Support training of authors/reviewers through guidance and expertise of system and tools for efficient authoring and review process
• Support the creation and maintenance of CMC submission templates
• Maintain team compliance with company trainings and internal processes and standards
• Collates source documents pertaining to regulatory filings/submissions on request
• On occasion will QC selected CMC sections of regulatory filings
• Project team participation as necessary, information gathering, progress reports and presentations etc.
• Proactively seeks input, feedback and assessment from key stakeholders to drive business improvements
• Assists in the development and implementations of departmental processes, procedures and policies.
• Active promoter of talent, knowledge sharing and collaborative spirit.
Education and Experience Requirements
Include educational requirements or equivalency, required years and type(s) or experience, and necessary licenses or certificates.
• Degree in Pharmaceutics, Chemistry Chemical Engineering, or closely related field is desired.
• Minimum 3 years’ experience in the Pharmaceutical Industry, or relevant Regulatory environment.
• Familiarity with pharmaceutical product/process development, regulatory guidelines and experience in regulatory submissions (in particular CMC Module 3 information and QOS documents) throughout out the development lifecycle is desired.
• Experience with EDMS (documentum) and publishing tools is essential
• Knowledge of Submission Ready standards application is required
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