Director, Regulatory Affairs Information Management

The Director of Regulatory Information Management (RIM) is responsible for translating broader Regulatory Information Management Services (RIMS) and Regulatory strategy into execution within assigned scope, advancing regulatory information capabilities, and ensuring efficient, consistent, and compliant management of Regulatory information.This position provides strategic leadership for business processes, data quality, system enhancements, and continuous improvement initiatives within area of responsibility. The Director partners closely with Regulatory, BTS, Business Process Owners, and other cross-functional stakeholders to deliver business value, strengthen compliance, and improve operational effectiveness.The Director manages a small team and is accountable for team performance, capability development, and delivery of high-impact work within assigned scope. While the role has broad cross-functional influence, it is not accountable for the full RIMS organization strategy, operating model, or enterprise-wide portfolio prioritization.

Responsibilities:

Lead a defined RIMS capability area and team to deliver efficient, compliant, and business-aligned regulatory information management processes and solutions.

Translate functional strategy into execution plans for assigned scope, ensuring initiatives, priorities, and resources are aligned to broader RIMS and Regulatory objectives.

Manage and develop a small team of RIMS professionals, including setting goals, assigning work, coaching performance, supporting development, and building capability to meet business needs.

Provide strategic leadership for the design, implementation, and continuous improvement of RIM processes, data practices, and enabling technologies, including the RIM solution (Cosmos), within area of responsibility.

Partner with BTS, Regulatory Business Process Owners, SMEs, and cross-functional stakeholders to identify, prioritize, and deliver enhancements that improve quality, compliance, user experience, and operational efficiency.

Maintain strong knowledge of Regulatory business processes across the product lifecycle and apply that knowledge to shape practical, scalable solutions that support Regulatory strategies and enterprise needs.

Oversee data quality, integrity, and governance activities within assigned area, leading efforts to identify issues, resolve discrepancies, and strengthen compliant management of regulatory information.

Define and monitor KPIs and operational metrics for assigned scope, providing leadership with meaningful insights on performance, risks, trends, and opportunities for improvement.

Support inspection and audit readiness activities by leveraging expertise in regulatory information, documentation practices, and process controls, and by partnering with broader Regulatory and RIMS leadership as needed.

Lead complex cross-functional initiatives through direct leadership and matrix influence, aligning stakeholders, resolving issues, mitigating risks, and driving execution to achieve business outcomes.

Represent assigned RIMS area in governance forums, business discussions, and selected external interactions as appropriate, serving as a credible and effective subject matter leader.

Frame complex issues clearly for decision-makers and develop recommendations, business cases, and presentations that enable timely and informed decisions.

Required Education:

Bachelor’s degree in business management, information systems, engineering, math, science (e.g., biology, chemistry, pharmacy, medical), or related field

Required Experience:

10+ years of pharmaceutical, device, or related industry experience

Experience in Regulatory Affairs, Regulatory Operations, Regulatory Information Management, or closely related discipline

Experience leading complex cross-functional initiatives in a matrix environment

Strong communication skills, both oral and written

Strong business acumen and influencing skills

Experience working in a complex, highly matrixed environment

Ability to develop strong business cases and advance new ideas

Strong project planning and management capability, including successful implementation of complex initiatives

Demonstrated ability to translate strategy into execution and drive results through leadership and influence

Preferred Experience:

Experience leading a team

Prior experience with Regulatory Information Management systems and processes, including Cosmos or similar platforms

Experience with data governance, process improvement, and inspection readiness activities

Experience partnering across Regulatory, BTS/IT, Quality, Clinical, Safety, or related functions

Demonstrated success leading change and driving adoption of new processes or technologies

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will …