Recruitment Fraud Alert
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If you believe you have been contacted by an unauthorized person, please contact your local law enforcement agency immediately.
Senior Manager, Global Regulatory Affairs, Regional Compliance
- Provide leadership and expertise in the identification, creation, and execution of GRA Compliance initiatives to drive overall compliance and growth, within the Regional and Local Operating Companies (LOCs) located within the region, while meeting Takeda corporate objectives.
- Lead and manage the operational activities, compliance and implementation of Takeda’s Global Regulatory Affairs (GRA) processes and regional/Local Regulatory legislation requirements across applicable region and Local Operating Company (LOCs) who perform Regulatory Affairs responsibilities. Ensure alignment with global strategic initiatives related to Takeda regulatory quality and compliance.
- Responsible for preparing, managing, coordinating, and responding to audits and Health Authority inspections related to Global Regulatory Affairs processes within the regions/LOCs.
- Manage the communication, implementation of GRA processes, systems and procedures for GxP processes (e.g. training, change control, deviations/CAPAs, etc.) within the region/LOC ensuring execution and compliance.
- Monitor, communicate and determine impact on GRA processes of new/revised Regional/Local Regulatory Requirements.
- Lead the execution of inspection readiness activities for GRA processes within the region/LOCs
- Partner with the Regulatory Area Heads on key Regulatory strategic initiatives and/or issues ensuring compliance within the applicable region and LOCs
- Monitor and manage training compliance of Global Regulatory Affairs processes and procedures within the LOCs.
- Partner effectively with cross functional teams, in the proactive identification of key regulatory compliance issues with the ability to determine actionable project proposals and drive them to successful resolution.
- Provide Global Regulatory Compliance expertise in the development and maintenance of key compliance activities (e.g. labelling, CMC, and/or change control across Takeda.)
- Responsible for demonstrating Takeda leadership behaviors.
- Align GRA initiatives and implementation strategies with relevant stakeholders within the LOCs
- Evaluate GRA processes utilizing industry risk assessment tools and identify opportunities to mitigate compliance risk.
- Develop strong partnerships with cross functional leadership within the region and LOCs to optimize overall compliance within GRA.
- 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.
- Ensure the update and management of all regional/Local information/access sites/portals/distributions; and facilitate creation, implementation and maintenance of communications and effective change management of RA processes in region/LOCs.
- Oversee the development, implementation and understanding of GRA processes and systems and the impact on the regional/LOC RA representatives.
- 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.
- Lead and engage in efforts to simplify and optimize business processes and platforms to drive growth
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor’s Degree in a science or business-related field.
- 5+ years of experience in Pharmaceutical industry, with 5 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.