You’ll be responsible for continuously improving the efficiency, efficacy, and focus of the Pharma Development Regulatory Regulatory Strategic Support (RSS LT). You’ll work closely and cross-functionally with the each of the LT members, the Head of RSS, your peer-group of business managers supporting other functional areas, key process owners to run the strategic and operational rhythms of the business, and the head of business management. The RSS LT is comprised of the head of RSS, finance and human resource business partners, and the heads of Regulatory Documentation, Operations, Labeling, and Established Products Program Management.
The Pharma Development Regulatory organization develops and maintains the licenses that permit Roche to market and sell its life improving therapies worldwide. We are the stewards of the safety and efficacy of medicines, collaborating with regulators of every country in which Roche does business to help them understand our products’ clinical value. We also work across industry and regulators to continually evolve regulatory policy. We are an organization of ~800 staff with our main offices in China, UK, Switzerland, Canada, and the USA.
Regulatory Strategic Support collectively authors, publishes, and transmits the submissions that secure and maintain health authority approvals.
Annual Operations Planning
Integrate various topics, decision requirements, and business area reviews into a cohesive rhythm / calendar that utilizes leadership team time effectively and delivers on the needs of the business and the Leadership Team remit. Topics will include the annual budget planning cycle, talent management cycle, strategic planning refresh cycle, goal setting, non-molecular initiatives portfolio management, functional area operations performance reviews and other business critical topics.
Determine and facilitate the highest value strategic decisions to be taken by the RSS LT considering the broader business context, external regulatory context, and departmental operating context.
Accountable for facilitation and execution of key communications within RSS and key partner to PDR communications lead.
Act as Business Manager where/when necessary in the larger sub-functions of RSS including Medical Writing and Operations.
Leadership Team Operations and Evolution
Establish LT meeting cadence and manage LT agendas so the RSS LT can make timely, well-informed decisions, allocate resources to the highest value uses, and has effective line of sight into the value delivered by the organization.
Design and facilitate effective meetings by selecting relevant topics, balancing content review with discussion, and moderating dialogue.
Drive, monitor and improve the overall effectiveness of the RSS LT by managing the team process and introducing solutions to build team effectiveness as necessary
Track and monitor LT decisions and actions; Hold LT members accountable to decisions and actions
Collaborate with your peers in other Pharma Development functions to shar best practice, align, and ensure consistency as appropriate
Collaborate with PDR administrative staff on all aspects of logistics and planning
Ability, knowledge and acumen to represent the head of RSS when necessary. This may include internal or external conferences, meetings or engagements.
Collaborate with your peers to deploy consistent approaches across functional areas
Collaborate with business process owners and your peer group to develop and deploy consistent approaches across RSS LT for the following activities:
Develop Vision & Strategy
Manage Initiatives Portfolio
Strategic Workforce Planning
Manage Human Resources
Manage PDR Performance
Who You Are
Qualifications, Experience & Education
A deep history of prior business experience (5+ years) in the biotechnology and pharmaceutical arena is required
MBA or MS in Management or other advanced degree showing a focus in business is highly valued but not required
Knowledge of Regulatory Affairs is highly valued but not required
Green Belt certification and/or Continuous Improvement experience is highly valued but not required
A strong leadership presence; You will be viewed and recognized as a thought leader
Ability to cultivate a strong and trusting relationship with executive leaders
Ability to provide clear, informed, and sophisticated counseling to executive leaders
Outstanding time management and organizational skills, with an ability to consistently execute multiple, and sometimes competing activities to a high quality and timely conclusion
Ability to quickly assimilate and prioritize changing business requirements into in-flight strategies and plans
Ability to see the connections between seemingly disparate issues, as well as distill complex and sometimes voluminous content into clear, concise, and engaging communications
Outstanding communication and presentation skills, both written and verbal
Strong influencing and negotiation skills, including a record of accomplishment influencing without authority and driving cross-functional activities to successful conclusion
Strong customer-orientation and proven track record of collaborative work relationships
Additional Information about the Role
Reports to Head of PDR Business Management within the Regulatory Business Office
The RSS LT is a global team; international travel is required as well as ability to work during overlapping hours between the EU and US PDT
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.