OBJECTIVES: (Briefly summarize the overall purpose of the position. Objectives should
be written in 3 4 bulleted statements).
- Responsible for managing and executing assigned regulatory compliance activities of all levels of complexity in support of Global Regulatory Affairs Quality and Compliance systems, including working with internal and external staff. This may also include regulatory compliance activities associated with Takeda cross functional sites and groups.
- Provides subject matter expertise in support of Takeda quality systems used in Regulatory Affairs (i.e. eQMS Change control, Registration Tracking Systems as it relates to change control and GPP creation) as needed including providing global support both internally and externally to regulatory affairs, coordination and execution.
- Supports the execution of Regulatory change controls as they relate to product labeling, CMC change, withdrawals and others through providing guidance and coordination of the global regulatory assessment.
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).
- Lead and support the awareness and training across Global Regulatory affairs function to promote understanding in the execution of change control.
- Supports the management and production of Global Regulatory Affairs Compliance metrics.
- Serves as a resource and subject matter expert (SME) for systems, providing a bridge between the responsible functions and Global Regulatory.
- Identifies, escalates, and proposes solutions regarding alignment with Takeda processes and requirements
- Identifies training needs and conducts or supports training as necessary.
- Provides subject matter expert support for potential regulatory impacted change controls.
- Reviews global regulatory change control performance data and prepares reports to track accomplishments and productivity.
- Coordinator of initiatives as assigned to support Global Regulatory Compliance projects.
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.
- 3+ years of experience in Pharmaceutical industry, with 3 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
- Stong 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