Global Regulatory Submission Manager

• Lead and manage multiple and simultaneous global regulatory submissions in eCTD and non-eCTD formats components.  

• Drives cross-functional teams focused on the planning, overseeing compilation activities, and dispatch of worldwide regulatory HA submissions, anticipating technical obstacles and developing solutions.  

• Negotiate timelines, manage global stakeholder expectations, publishing team and leadership communications. 

• Provide guidance to global project teams on worldwide HA submission format/requirements, filing strategy, eCTD document lifecycle management and submission compilation workflows 

• Plan, manage and track delivery of submission components, coordinate submission publishing activities with publishing team, organize submission review and approvals.     

• Partner across multiple cross functional functions, troubleshoot submission technical / quality issues and manage the efficient use of global resources. Organize, lead and participate in both internal and external stakeholder meetings (including acquisitions, partnerships and divestiture efforts). 

• Develops/implements solutions to create efficiencies and effectiveness. 

Your Experience: 

• Bachelor's degree in life sciences or relevant discipline.  

• Regulatory affairs or regulatory submissions related experience in global HA regulatory formats and submissions publishing activities. 

• Familiarity with the drug development process, global HA regulations/ guidance e.g. FDA, ICH, EMA, MENA, CH. 

• Proven enterprise mindset and quality driven  

• Strong interpersonal/project/time management skills and experience managing through complexities in a fast-paced, global cross functional organization. 

• Effectively works as part of a team environment or independently. 

• Strong project management skills: Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines 

• Decisive, solution-oriented, pragmatic, customer focused, readily adapts to changing priorities and composed under pressure. 

• Demonstrated negotiation skills and a positive attitude. 

• Demonstrated ability to build productive relationships and influence stakeholders across the organization.  

• Results driven and action oriented. 

• Highly motivated, self-starter, forward thinker. 

• Strong communication and business writing skills 

• Strong technical skills and business savviness;  

• Working knowledge of publishing tools (e.g., DXC (eCTDxpress/Publisher),Veeva), global submission validation tools, Document Management systems, Toolbox, HA electronic submission gateways, IRIS, CTIS, MS Office tool 

• Familiarity with submission publishing/compilation principles is ideal  

• Fluency in 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 

Commitment to Diversity & Inclusion: 

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve. 

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