Clinical Operations and Regulatory Affairs, USA | 31 Mar 2021
Global Regulatory Submission Lead
Global Regulatory Submission Lead
Directly report to:
Director, Regulatory Operations
Hutchison MediPharma (US) Inc.
Manages and/or performs all aspects of electronic dossier compilation and publishing associated with US and EU health authority submissions for market approval and product maintenance to health authorities worldwide.
Works independently in preparation and coordination of electronic submissions according to HMP milestones and in compliance with relevant health authority regulations. Incumbent has full responsibility and accountability across multiple assigned drug projects including all types of electronic submissions for both new products and/or marketed product maintenance packages. This includes both domestic and international submission types (e.g. IND, NDA/sNDA, MAA, CTD/eCTD, CTA/IMPD, PSUR, Agency Meeting Briefing Packages, Major Variations, Product Renewal, CMC amendment, IND/NDA annual report, information amendment, DMF update, Advertising and Promotion, etc.)
Uses technical knowledge/experience to work independently and apply problem-solving skills to address issues with software functionality and/or publishing output. Accountable for thorough quality assurance, validation, and release of dossiers for dispatch to HA.
Regularly interacts with various levels of cross functional colleagues and CROs, on document authoring (e.g. templates, styles, bookmarks, hyperlinks, etc.)
Familiarity with electronic document management system and international workflow processes, including implementation and maintenance of electronic submission/document management standards, processes, and procedures which apply internationally and across disciplines.
Assists in the evaluation and validation of new software functionality or IT-systems used in the electronic submission process.
Major Tasks and Responsibilities
Plans, coordinates and conducts all aspects of electronic and paper submissions that are sent to respective health authorities.
Work with team to identify critical path of submission and track all relevant dossier components to ensure planned dispatch date and high quality dossier
Assist in the development of submission project planning and alignment of functional timelines for major global and regional submissions, while providing support for international submissions.
Performs compilation and publishing activities including generation of electronic TOCs, bookmarking, and hypertext linking for agency reviewers. Submission types to include all potential dossier types worldwide across all phases of a product lifecycle including INDs, NDA/sNDAs, MAAs, CTD/eCTDs, CTA/IMPDs, PSURs, Agency Meeting Briefing Packages, Major Variations, Product Renewals, CMC amendments, IND/NDA annual reports, information amendments, DMF updates, Advertising and Promotion, etc.
Accountable for thorough quality assurance of validation technical errors, reconciliation, release of dossiers prior to submission.
Incumbent assists in the implementation and maintenance of electronic submission document management standards (e.g. MS Word templates, training documents etc.), processes, and procedures that apply internationally and across disciplines. Also assists with development and maintenance of operational guidelines and best practices in accordance with Health Authority Regulations and Global HMP standard operating procedures (SOPs).
Minimum of 9 years in the Pharmaceutical Industry without a degree, with a minimum of 6 years of direct pharmaceutical regulatory submissions operations experience, or a BS/BA Degree and a minimum of 5 years in the Pharmaceutical industry/ regulatory affairs or a MS/MBA Degree with a minimum of 3 years in the Pharmaceutical industry /relevant experience in regulatory affairs.
BS or equivalent (degree preferred) in a life science or computer science and 5-6 yrs. relevant experience. Alternatively, an MS in a life science or computer science and 3-5 yrs. relevant employment experience.
Relevant experience may be met by a combination of electronic data/document management, computer systems or publishing software support, technical manual writing & training, copy editing, electronic document publishing, and/or regulatory affairs.
NDA, BLA, MAA, IND and/or CTA / CTN filing experience a plus
Incumbent should have familiarity with government regulations and international standards (e.g. ICH, IBH)) as they pertain to the planning and the development of electronic submissions
Hands-on experience required with various document types and file formats (such as MS office suite, PDF file rendering, SAS program/transport files, XML program code, etc.) plus previous experience with document management, electronic document management systems (eDMS), and/or electronic publishing tools such as VEEVA, Lorenz, Global Submit, ESG FDA Gateway, ISI toolbox, preferred.
Must be flexible, and capable of supporting multiple projects. Must be highly organized and maintain the necessary procedures to ensure all projects are completed according to agreed timelines.
Strong communication and interpersonal skills to support interactions with global document authors, CROs, and international HMP functional teams.
Exposure to the project management function, tools (MS Project) and techniques as they apply to Regulatory submission projects is highly desirable. Self-motivation, a sense of urgency, attention to detail, sound judgement, and good follow-through are also essential