OBJECTIVES: (Briefly summarize the overall purpose of the position. Objectives should
be written in 3 4 bulleted statements).
- Responsible for managing the strategic, operational activities and implementation of Takeda s Global Regulatory procedures and processes within Global Regulatory Affairs ensuring alignment with global strategic initiatives related to regulatory quality and compliance.
- Participate on Strategic Initiatives and/or Task Force activities to address potential Compliance issues raised across global RA and R&D platform. Ensure that Takeda is aware and responsive to external guidelines and regulations as they pertain to quality management and compliance.
- Establishment of a cross functional Compliance Forum or Center of Excellence across all functions within the Global Development Office groups.
- Responsible for managing, coordinating, and follow up on audits and inspections related to Regulatory Affairs processes globally.
- Manage the monitoring of compliance to GRA processes, systems and procedures with GRA QMS (e.g. training, change control, deviations/CAPAs, etc.) across GRA.
- Oversee the execution of inspection readiness activities for GRA processes.
- Establish and execute overall processes for monitoring and reporting the effectiveness and compliance of applicable GRA functions (i.e. CMC, Labeling, Reg. Operations etc.) through metrics, dashboards, internal assessments and others.
- Responsible for establishing a process for tracking of Regulatory interactions and commitments within GRA.
ACCOUNTABILITIES: (Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 10 bulleted task statements should be identified).
- Responsible for demonstrating Takeda leadership behaviors.
- Lead critical GRA projects for QMS and Compliance for both strategic and operational optimization, compliance and effective implementation
- Monitor, interpret, and communicate regulatory QMS requirements, new/revised global regulatory GxP requirements and leads communication efforts to global RA persons on changes/updates to the QMS.
- Oversee the update and management of all Global RA sharepoints/distributions lists; and facilitate creation, implementation and maintenance of communications and effective change management of RA processes in region/LOCs.
- Co-development of relevant GRA metrics to track key QMS and compliance initiatives, including partnership with Strategic Initiatives and Strategic Planning directors as well as other cross-functional partners within Takeda. Communicate issues/trends to GRA leadership.
- Oversee the development, implementation and understanding and of GRA processes and systems and the impact on the regional/LOC RA representatives. Ensure internal review of SOPs from other functional areas.
- Collaborate and build relationships with regional/LOC team members for the development and implementation of RA controlled quality documents and training materials describing GRA system related business processes via team members.
- Partner with Regional/LOC QA/Pharmacovigilance functions and interface with all disciplines in the identification and understanding of the inter-relationship between the different functions in respect to RA complaince. Ensure business critical gaps identified are closed.
- Inspections/Audits: Responsible for regional/LOC regulatory inspection or internal audit readiness for dedicated GRA/QMS/GxP inspections/audit; Ensure all inspection and audit issues related to Global RA and findings are addressed adequately; Partner with LOCs and global cross-functional partners in local inspection/audit activities as needed; and oversee corrective and preventative action plans (CAPAs). Support regional/LOCs in addressing issues identified in CAPAs as needed.
- Lead development of training material and perform training as needed for internal/external stakeholders in relation to compliance and overall QMS activities. Ensure that training processes are compliant with relevant GRA/Local LOCs regulations. And, ensure the development of core competencies and measurement of performance (according to national law) against departmental goals and expectations.
SCOPE OF SUPERVISION:
NUMBER SUPERVISED WORKERS
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.)
Education and Experience Required:
- Bachelor s Degree in a science or business-related field.
- 8+ years of experience in Pharmaceutical industry, with 6+ years in Regulatory Affairs, research and development, quality assurance/compliance.
- Familiarity with inspections and audit procedures.
- Ability to identify proactively and anticipate risk of non-compliance in a complex environment.
- Demonstrated knowledge of global health authorities, regulations, product approval and lifecycle processes for major markets and of pharmaceutical and regulatory affairs requirements and practices.
- Practical operational experience of working across disciplines and across multiple regions. Experience working within a global team framework and a multi-cultural environment. Efficiently/actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties.
- Able to manage both time and priority constraints and to manage multiple priorities simultaneously.
- Capability to critically analyze complex and/or ambiguous information and the impact on products and process and to effectively communicate complex issues both verbally and in writing.
- Excellent analytical, technical and problem-solving skills
- Strong communication skills with the ability to express oneself clearly and concisely to a variety of audiences. Ability to understand/analyze/synthesize and communicate to internal/external stakeholders.
- Must be able to lead cross-functional and cross regional teams and deliver results in a matrix organization. Excellent organizational skills and ability to prioritize as well as Project Management abilities.
PHYSICAL DEMANDS: (Identify any physical demands required in the performance of the primary responsibilities of the position).
- Routine demands of an office-based environment.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Ability to sit or stand for long periods of time while traveling
- Willingness to travel to various meetings, including overnight trips.
- Requires approximately up to 10-30% travel.
ADDITIONAL US SPECIFIC INFORMATION (FOR US RECRUITMENT ONLY): E.g. Number of years experience, ADA
ADDITIONAL EUROPE SPECIFIC INFORMATION (FOR EUROPEAN RECRUITMENT ONLY): This section should reiterate minimum/essential requirements for role