Summary
Train and guide authors and contributors on regulatory submission requirements. Mentor/coach less experienced team members within BR Submission Management.
About the Role
• Manage the preparation of the BR submission components of regulatory submission dossiers such as IND, NDA, MAA (i.e., medium to high complexity submissions).
• Leads submission planning discussions, developing, and maintaining a comprehensive strategic submission plan including a detailed list of dossier content, interdependencies, key activities, target governance board review timeframes, content delivery timelines, and credible dispatch dates and executing this plan.
• Ensure the submission team are aligned of upcoming deliverables and roles and responsibilities and that they understand the interdependencies between submission activities and components, and that any issues, risks, or impact due to changes in strategy and/or timelines are assessed quickly and remediated, throughout the submission process.
• Utilizes strong knowledge of global regulatory submission requirements, processes and procedures, technical requirements, and planning software to ensure teams meet aggressive target submission dates, by proactively focusing on critical path analysis, hand-offs, and prospective scenarios (when multiple regulatory strategies are being considered), thus reducing "rework" to avoid costly time delays.
• Collaborate with Document Quality Management team and other key partners such as BR Quality to ensure strategic resource planning of downstream activities allowing deliverables to me finalized in accordance with targeted submission timelines.
• Performs the role of Investigator Brochure compiler for First-in-Human studies and subsequent annual updates in accordance with regulatory requirements and internal Novartis guidelines and SOPs.
• Provides various data visuals, to facilitate awareness of key milestones, closely monitors critical path activities, and ensures transparency of submission status to stakeholders.
• Provide strategic input relating to submission requirements for migration of submission related supportive documentation for in licensed/joint ventures and acquired assets. Managing the preparation of the subsequent dossier preparation therein.
• Mentor/coach less experienced Submission Management team members.
• May lead continuous improvement activities related to submission processes and regulatory document management within BR.
• Update assigned internal planning systems, to allow maximum transparency, thus ensuring strategic business decisions can be made for expeditious resource planning, both within Submission Management and cross-functionally within BR.
• Act as subject matter expert for submission related global cross-divisional strategic projects ensuring BR interests are represented.
Education / Background:
Undergraduate degree, preferably in a scientific discipline or life science background or equivalent work experience
Years of Experience:
3-5 years’ experience working in a regulated, life science environment (pharmaceutical, biotechnology)
Key Competencies:
• Comprehensive understanding of relevant technical requirements for electronic registration submissions (eCTD) e.g. Bookmarking, hyperlinking, cross referencing etc.
• Demonstrated ability to work successfully within a matrix environment and influence cross functional teams.
• Experience with and ability to understand compliance practices which include GxPs and Standard Operating Procedures
• Proficient in Microsoft Office suite in addition to SharePoint.
• Strong oral and written communication skills and customer service skills and organizational skills.
• Self-starter with a proven ability to prioritize work, multitask, display customer centricity, and manage time appropriately, in a fast paced/high volume environment.
• Demonstrated organizational skills.
Languages:
Fluent oral and written English
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
