Regulatory Submissions Capability Lead

Hoffmann-La Roche Inc. South San Francisco , CA 94080

Posted 7 months ago

Roche are at the forefront of developing ground-breaking new medicines and consistently push the boundaries of conventional thinking and embrace innovation across our business. With a strong pipeline, we are looking for highly motivated people to support global teams to develop and gain approvals for medicines globally.

The end-to-end submission process is a critical accountability for regulatory within the Pharma value chain. It is increasingly important to ensure reduced time and cost of submissions in an increasingly competitive environment, while maintaining quality and compliance. Process, data and technology optimization are key enablers for this ongoing transformation.

We are offering a unique opportunity to join our Regulatory Team.

As the Regulatory Submissions Capability Lead (RSC) you lead a Portfolio of initiatives collectively aimed at improving the overall submissions capability. You establish the cross regulatory strategy development and implementation efforts to deliver new processes, technologies, and ways of working for all regulatory functions (Product Development Regulatory (PDR), Product Technical Regulatory (PTR) and Drug Regulatory Affiliates (DRAs)).

Your key responsibilities are:

Manage the RSC Portfolio.

You oversee the roadmap for the Regulatory Submissions Capability (RSC) and ensure clearly defined objectives, deliverables, resource requirements, external spend requirements, and strategic objectives for each initiative in the RSC Portfolio according to the roadmap.

For new initiatives, you develop creative, compelling and clearly articulated business cases describing how the initiative addresses the RSC goals; defining clear scope and intent and how the initiative will support achievement of target levels of RSC maturity and / or direct business benefits. You create and implement a metrics architecture to assess value of the capability's new ways of working and to drive behaviors needed to sustain and institutionalize target maturity.

Build and maintain effective working relationships with business leaders, stakeholders, users and partners to integrate initiatives / programs into RSC and overall PDR & PTR strategic objectives. You create a compelling RSC vision for the future and cascade that throughout regulatory functions (PDR, PTR and DRAs) and to cross-functional stakeholders. To secure the talent required to mobilize and execute the portfolio of initiatives you collaborate with resource managers internal and external to regulatory.

Lead the RSC Strategy & Roadmap annual refresh cycle. You trigger and manage periodic strategy refresh for the RSC to continually advance our vision and capability targets based on evolution of the business, the regulatory environment and emergent technologies and methodologies. In sync with PDR and PTR budget and goals cycles you identify, design and deploy new strategic initiatives to introduce to the RSC portfolio.

Build and lead the RSC Portfolio Team. You build, coach, motivate and challenge a team of talented initiative leaders and program area leaders responsible for delivering elements of the RSC Portfolio.

You create a high performing high impact team while operating in matrix management environment. You establish best practices for project and program management and cascade this down through all-levels of the Portfolio hierarchy.

Oversight of vendor and external budget. You identify, select, retain and manage vendor partners that may aid in delivering our transformations and oversee corresponding budgets.

What else are we offering?

We are dedicated to support our staff in development of their knowledge and skills and offer further career opportunities locally and globally where people demonstrate talent and aptitude.

Who are we looking for?

We are seeking a committed individual who brings:

  • Prior business experience (10+ years) in the biotechnology, pharmaceutical arena, or related industry. At least 5 years' program management experience, with exposure to the design and administration of business strategy development and execution. Knowledge of Regulatory Affairs is highly valued but not required

  • Strong leadership presence: you are viewed and recognized as an inspirational thought leader. You are able to cultivate strong and trusting relationship with executive leaders.

  • Ability to identify strategic needs, lead all aspects of planning, generate sound business recommendations, and secure alignment with key business partners. You quickly assimilate and prioritize changing business requirements into in-flight strategies and plans

  • Ability to see the connections between seemingly disparate issues (i.e. systems thinking), as well as distill complex and sometimes voluminous content into clear, concise, and engaging communications

  • Strong influencing and negotiation skills, including a record of accomplishment influencing without authority and driving cross-functional activities to successful conclusion

  • Ability to travel (up to 50%)

Ready to apply?

Roche is an equal opportunity employer.

Business Development, Business Development > Strategic Business Development



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Regulatory Submissions Capability Lead

Hoffmann-La Roche Inc.