Senior Specialist, Regulatory Affairs Business Operations

Role Summary

The Senior Specialist, Regulatory Affairs Business Operations manages low-to-medium complexity business processes and project management support for the Regulatory Affairs function. With support from management and by fostering efficiency through data analysis and process management, this role is integral in ensuring resources are optimally utilized and processes are aligned with organizational priorities. This resource may also play a support role in broader initiatives that may contain business processes and/or technology components.

Responsibilities

• Provides business support for globally deployed applications, including supporting appropriate training, granting applications access, and maintaining process models.
• Tracks risks and mitigation plans; tracks issues and facilitate resolution.
• Perform data analyses that provide insights to support decision-making. Gathering and reporting of business process metrics, trends, and standard reporting on an established cadence.
• Works with the RA Business Ops team, R&D and BTS partners to understand existing and upcoming process and technology initiatives to support new and enhanced business support capabilities.
• Apply innovative solutions to enhance operational and analytics processes.
• Manage business operations to ensure processes are efficient and strategically aligned. Ensure systems and tools are used efficiently to support operational objectives.
• Communicates information regarding projects concisely and effectively to project stakeholders.
• Works well in a global and matrix team environment; interacts effectively across RA sub-functions and related organizations across the globe.
• Develops effective working relationships with team members, with a strong focus on delivering value to customers.

Qualifications

• Required: Bachelor's degree preferred in a business, finance, technical, scientific, or project management-related discipline and 4+ years professional work experience, preferably in operations management, data analytics, or the pharmaceutical or biotech industry; or Master’s degree with 2+ years of work experience.
• Excellent interpersonal, problem-solving, and strong data analytical skills. Demonstrated history of successful execution in a fast-paced environment and managing multiple priorities effectively.
• Ability to work independently and represent sound strategies is required.
• Preferred: Experience analyzing complex business problems and facilitating the design of innovative business and/or technology solutions.
• Preferred: Experience working in a complex and matrixed environment.

Additional Requirements

• Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required.