תקציר
About the Role
Major accountabilities:
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.
Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network