Regulatory Process Excellence Manager

Join a Legacy of Innovation 125 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders

Job Summary:

The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (e.g., Quality, CSPV, Clinical Operations, Clinical Development, RA CMC) to keep processes, procedural documents and supporting job aids up to date, and to facilitate the use of effective, harmonized processes globally.

This role will be responsible for coordinating the authoring, review and approval of new or updated procedural documentation. In addition, this role will work closely with process owners, subject matter experts (SMEs) and Quality colleagues within R&D and cross-functionally, to facilitate, roll-out and track just-in-time, role-based training, as processes and ways of working are revised. He/she may also serve as a key regional point of contact for cross-functional process and procedural document related questions. The individual in this role will also be responsible for overseeing inspection readiness and supporting internal audits and Health Authority (HA) inspections. For any non-compliances / potential non-compliances identified, this role will be responsible for conducting root cause analyses, documenting/tracking associated CAPAs or process deviations, and coordinating the end-to-end management of these. They will also be responsible for conducting proactive risk assessments related to regulatory processes on a consistent basis and identifying areas of potential non-compliance or operational risks.

Responsibilities:

• Maintain regulatory procedural documentation, in line with company-wide policy and relevant regulatory requirements

• Coordinate with broader DS quality teams to support GRA meeting company policies for quality management (e.g., completing requests/initiatives from the GSOP Committee)

• Proactively manage required periodic review for controlled procedures

• Ensure global and cross-functional consistency of process documentation to the extent possible by coordinating reviews and updates with relevant process owners / SMEs

• Monitor key GRA process performance / adherence / metrics to proactively address operational risks

• Serve as a regional Process expert regarding maintaining a compliant set of procedural documents

• Work with RA and cross-functional stakeholders to update processes and procedural documentation, define metrics/KPIs and coordinate training for teams

• Coordinate redesign/update of key processes and associated documentation as necessary; this may include facilitating cross-functional meetings to align on process changes and coordinating timelines and responsibilities for authoring, review and approval of procedural documents

• Serve as a facilitator for process updates that may include new ways of working with existing or new systems (e.g., Vault RIM)

• Work with GRA stakeholders to define appropriate KPIs/metrics to track process compliance, performance and adherence

• Work with the data/systems SMEs to define reporting needs to oversee process performance

• Share and review data/metrics with the GRA Analytics Team

• Coordinate the development and roll-out of training for changes to processes / ways of working

• Support Regional and Functional Leads in management of Role Based Curriculums

• Drive continuous improvement of GRA processes and ways of working

• Drive activities required for GRA to be inspection ready, and support addressing any observations or findings that may result from audits and inspections

• Work with QA to understand and provide input to the planned schedule internal audits and mock inspections

• Support inspection readiness including maintaining access to relevant documentation / reports

• Support HA inspections or internal audits as needed, coordinating with relevant process owners and cross-functional SMEs

• Conduct root cause analyses for any issues identified, to define CAPAs/deviations

• Maintain a GRA database for tracking process deviations / CAPAs

• Coordinate activities required to resolve process deviations / CAPAs arising from either internal audit or HA inspection findings

• Work with cross-functional stakeholders to enable sufficient input and buy-in being received where needed

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education:

• Bachelor's Degree Data Science, Computer Science, Engineering, Statistics, or related field required

Experience:

• 4 or More Years Experience in quality management in the pharmaceutical industry and quality (GxP) requirements Experience with process mapping, process redesign and SOP authoring/coordination (Required)

• 3 or more years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory compliance frameworks (e.g., ICH, FDA, EMA) (Required)

• 2 or more years with experience working with international teams; strong understanding of cross-cultural environments and different business practices across key markets (Required)

• 2 or more years with experience coordinating and managing regulatory audits and inspections, incl. CAPA management (Prefered).

Travel:

• Ability to travel up to 10% Business travel

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.