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The Senior Associate will support regulatory submission/publishing activities for eCTD global submission dossiers according to Agency and ICH Guidance requirements for major filings, (IND, NDA, sNDA, Amendments, DMFs, etc.) and regulatory maintenance activities. Support global submission timelines and coordination of publishing activities of work-related experience required for this position. Solid knowledge of submission requirements for regional markets may be required to ensure the overall submission and quality of the dossier meets regulatory compliance.
Submission Management & Publishing Tasks:
• Manage assigned regulatory activity projects and closely collaborates with Senior Managers from GSM, Regulatory Affairs and other functional areas for the planning and publishing of regulatory submissions, monitoring submission forecast and ensuring timely high quality of regulatory submissions are submitted to health authority within required submission timelines. Publishing regulatory submissions (bookmarks, hypertext links, QC) scheduled to be submitted to regulatory agencies (e.g., FDA, EMA and Health Canada).
Publishing Tasks: Assists with hands-on daily submission compilation and publishing activities associated with preparation of various dossier types.
Submission Project Management:
• Manage the submission timelines with Senior Managers and regulatory affairs representatives, maintains the submission timelines, collect status updates from the Publishing Manager and subteam members, RA Leads and reports submission status and activities to various stakeholders. Provide metrics and project tracking to measure progress and keep project on track.
Business Process Development & Problem Solving:
• Participate and contribute to new and updated process and procedures. Review regulatory documents to ensure compliance with submission guidelines to drive efficient future state process including gaining buy in for key stakeholder and drive to standardization of processes.
• Identifies risks and opportunities and addresses as needed with a focus on regulatory compliance requirements by supporting best practices, Working Procedures and SOPs.
• Support process updates due to changing regulations that impact submission strategies and technologies, SEND, CDISC, Validator Software, etc. This includes not limited to identifying the validation checks needed to ensure compliance with eCTD Specifications for world-wide regulatory agencies.
• May participate on internal project teams in order to guide and update business processes, as applicable.
Regulatory Information Applications & Technology:
• Support technology activities to ensure that regulatory information applications and systems are implemented, validated, and maintained in accordance with regulatory requirements compliance including but not limited to performing UAT scripts).
• Support Global System development and process development on a basic level, and process redesign.
• Technical knowledge of the US and global regulatory requirements for electronic submissions.
• Support and coordinate training to global submission management, regulatory publishing and other functional areas.
Regulatory Submission Intelligence:
• Perform and collect regulatory information applicable to global electronic submissions guidance, publishing tasks, data standards, and technology and marketing trends in regulatory space. Ability to gather data, analyze research material information and communicate to management potential impact on regulatory operations strategies, and/or identify hot topic issues.
• Responsible for staying abreast of US, Harmonized (ICH) eCTD and Global guidance's, and provide updates as required.
• Strong Communication Skills: Excellent verbal and written communication skills with demonstrated ability to present and articulate requirements with regulatory affairs members and regulatory colleagues proactively. Ability to foster and maintain relationships with strategic global regulatory organization and other functional partners to ensure understanding of current processes.
• Project Management Skills: Strong project management skills with attention to detail, ability to work in a fast-paced environment while successfully prioritizing and working on multiple tasks while utilizing organizational skills.
• Regional Regulatory Submission Knowledge: US Specific: Familiarity with FDA & ICH Regulations & guidelines, IND, NDA, sNDA, Amendments, Annual Reports, Orphan Drugs, Module 1 - Cover letter, forms, labelling & SPL, administrative information, Module 4 – STF, Module 5 –STF related to IND and marketing applications.
Serve as the Subject Matter Expert (SME) regarding eCTD processes and procedures.
• Knowledge of Drug Development: Experience in regulatory operations or regulatory affairs with advanced knowledge of pharmaceutical development (e.g. CMC, Nonclinical, Clinical)
• Technology & Software Skills: Advanced working knowledge of global eCTD publishing and Electronic Document Management technology, ISI Toolbox, Regulatory Tracking Systems (RTS) and related technology applications. Advanced user skill in MS Word, MS Sharepoint, Adobe Acrobat Professional, eCTD content templates and experience.
• Teamwork Skills: Experience in working on teams and to establish effective relationships with team members.
• Critical Thinking and Problem Solving Skills: Ability to track regulatory eCTD submission changes (e.g. regional DTD upgrade or system upgrades) and interpret potential implications for regulatory activities, training and/or timelines. Ability to identify the root cause of problems as well as the implications associated with potential solutions and communicate to management.
• Education Requirements (degree, certifications, etc.):
Bachelor's Degree required, preferably in science or health related discipline
Minimum 3-5 years pharma experience, including at least 1-2 years submission experience
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