US-TX, Sr. Global Regulatory Submission Manager 218334BR-MZ
Sr. Global Regulatory Submission Manager
Global Drug Development
REG AFFAIRS GDD
Fort Worth, TX
Research & Development
Leads and delivers high quality submissions (electronic and/or paper) to the appropriate Health Authorities according to upper management s target submission dates. Technical Format Expert both at Health Authority and key business meetings. Provides strategic and operational expertise to project teams. Achieves timely submissions/approvals according to business objectives and secures adherence throughout the company to regulatory requirements relating to the Technical Format. Partners the Global Therapy Area Leads and liaises closely with Reg Affairs Managers in order to incorporate Health Authority requirements.
Global Submission Manager leading major dossier submissions from a Global perspective and dispatches to worldwide Health Authorities (FDA, EMA, LATAM, ROW)
Liaises with a team of Global Submission Managers and Publishers who are located in EH, Switzerland and India. Works in a global capacity with colleagues across these regions
Key participant in Health Authority meetings representing the business as the expert on the Technical Format
Delegates submission activities to GSP (Global Submission Publishers) and GSM (Global Submission Managers) located in India, EH and Switzerland
Provides strategic and operational expertise to project teams to ensure the timely, quality preparation and execution for electronic and paper submissions to Global Health Authori-ties (EMA, FDA, Swiss Medic, LATAM, ROW)
Determines submission requirements for Health Authority (HA) interactions with Global Program Reg Director and/or Global Program Reg Managers
Develops and implements Technical Format requirements with other line functions and collaborates with RA Operations Submission Standards and Strategy team members to develop a company business guidance on format deliverables
DRA Operations leader on project teams within the assigned franchise and main contact for all submission activities related to assigned projects including working with external partners.
Provides expert advice and guidance to project teams regarding the format of regulatory submissions.
Responsible for managing all aspects related to the preparation, tracking, compilation, publishing and technical quality control of all assigned regulatory submissions. Ensure adherence to internal standards and processes, as well as Health Authority s require-ments.
Offers strategic and operational expertise to assigned project teams to ensure the timely, quality preparation and execution of major paper and electronic Health Authority submis-sions
Plan, implements, orchestrates and leads the submission tracking meetings. Owner of the submission tracking tool. Proactively tracks individual documents and submission time-lines.
Partner with LF (Clinical, Preclinical, Research and Technical) Coordinators (or designee) to negotiate every submission component target date with the goal of achieving the target submission date. Challenges submission timelines to ensure both a quality and timely delivery of submission components
Proactively troubleshoots technical/quality issues relating to the preparation and dispatch of submissions. Liaise with counterpart and applicable LFs (e.g., DiT, Clinical etc.) for problem solving (ensuring agreed upon action is implemented at the local destination).
Reports and updates Franchise Head for Submission Management on submission pro-gress. Provide status report to GPRD, project team and line management within DRA. Identify issues and solutions relating to timing, quality and resources.
Continuously looks to improve the submission process (i.e., updates existing business processes, authors new processes, etc.) and knowledge transfer within DRA Ops.
Business team lead on IT project teams regarding the evaluation and testing of new tools and technologies to ensure adherence to Health Authority requirements as well as internal standards. Authors documentation to support new tools and technologies. Implements and deploys new processes.
Represents DRA Ops on cross-functional project teams (non- submission related activi-ies).
Participates in other department activities / initiatives as required.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
University degree or equivalent in a scientific discipline such as biology, chemistry or pharmacy
Fluent in English (oral and written). Additional language is an asset
8-10 years of relevant experience in managing, compiling, publishing and/or handling global regulatory submissions.
Extensive knowledge of the organization of Health authority submissions
Knowledgeable of document management software and the concepts required to produce regulatory submissions
Effective interpersonal skills
Extensive project management, teamwork, communication (oral and written) and organizational skills.
A proven team leader
Highly motivated and self-starter
Proven negotiation skills
Fluent in computer software (e.g. MS Office Products i.e., Word/Excel/PowerPoint, Windows XP, Lotus Notes mail, Adobe Acrobat w/plug ins, etc.) and ability to learn new systems quickly.
Broad understanding of XML technology as applied in the field of eCTD, Structured Product Labeling (SPL) or PIM.
Expert knowledge of drug development, international drug registration and approval processes and related document format requirements.
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