Job Description

General Summary:

The Regulatory Affairs Business Operations Director leads the overall management of the Global Regulatory Affairs (GRA) resource plans and budget. This position will report directly to the Senior Director of Regulatory Compliance and Business Operations.

Key Duties and Responsibilities:

• Provide oversight and maintain accurate assessment of all aspects of resource management for GRA full-time employees and temporary headcount (independent contractors, FSP staff) including open, approved and filled positions
• Lead resource planning/headcount/capacity forums for individual functions, as appropriate
• Provide oversight and maintain an accurate assessment of current and projected resource demand
• Develop processes that drive efficiency for resource planning
• Partner with key corporate stakeholders (i.e. Finance, HR) to provide central Global Regulatory Affairs oversight of the global cycles, such as long-range planning (LRP), AOP/Budget, and workforce planning for Global Regulatory Affairs to ensure spend and resource decisions are in line with strategic functional goals
• Develop, maintain and manage a continuous process for measuring and reporting on financial and workforce planning activities keeping leadership and other stakeholders informed of progress
• Engage GRA Leaders provide stakeholder input to develop strategy for resource planning for each functional area
• Lead collaboration with GRA Leaders, HR, and Finance in workforce planning, long-range planning, and budgeting activities to meet needs of dynamic portfolio and ongoing resource/capacity needs
• Facilitate ongoing meetings with HR and Finance regarding headcount forecasting and budget management

Knowledge and Skills:

• Experience managing financial and workforce planning activities, including financial reporting and analysis, and in-depth knowledge of Regulatory Affairs and/or Drug Development Lifecycle
• Experience with corporate planning cycles, including annual Budgets, Long-Range planning, and Workforce Planning.
• Demonstrated attention to detail, accuracy, and excellent analytical and problem-solving skills in a fast-paced environment.
• Results-oriented
• Excellent leadership and interpersonal skills with an ability to effectively work and problem solve within a multidisciplinary team
• Excellent verbal and written communication and presentation skills

Education and Experience:

• Typically requires a Bachelor's degree in Life Sciences or Business Administration
• Typically requires 10 years of experience in the biopharmaceutical industry or the equivalent combination of education and experience

We're enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you canchoose to work:

1.Hybridand work remotely up to two days per week;or select

2.On-Site andwork 5 days per week with ad hoc flexibility.

#LI-EE1 #LI-Hybrid

Company Information