Associate Director, Global Regulatory Affairs Labeling Compliance

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The Regulatory Affairs-Labeling, Associate Director is responsible for ensuring that Takeda gains regulatory approval for new products and product amendments, while maintaining the currency of product licenses and permits. This role helps ensure compliance with legislation and regulations, contributing to Takeda's mission of bringing better health to people and a brighter future to the world.

How you will contribute:

• The Associate Director, GRA Labeling Compliance, is responsible for the strategic and operational activities pertaining to global and local labeling compliance and quality within Global Regulatory Affairs.
• Partners with internal stakeholders and external CRO partners such as Global Regulatory Compliance, Global Labeling, IT, Global Regulatory Operations, GPSE (safety), Regulatory Therapeutic Areas, Local Operating Companies and Supply Chain on all matters related to global labeling compliance and quality.
• With the Director of Global Labeling Compliance, is responsible for successful labeling compliance and quality management, end-to-end tracking of global labeling updates, and implementation of Global Labeling processes.
• As a member of a growing Global Labeling Compliance organization, is involved in setting the direction for the team within Takeda, identifying and attracting the best talent to the organization, and strategizing the future of the organization with the Director of Labeling Compliance and others.

ACCOUNTABILITIES:

• Collaborates with Global Labeling leadership to ensure clear and timely communication about labeling compliance activities and metrics.
• Responsible for alignment with global strategic initiatives related to labeling events and the processes and systems used to manage labeling compliance.
• Development and leadership of the following activities at a global level in collaboration with Head of GRA Labeling Compliance:
• Responsible for labeling compliance-relevant strategic initiative activities which may impact labeling compliance and labeling processes (labeling event management systems, RIM systems, and quality documents).
• With Global Labeling Operations, develop new and updated processes for labeling and labeling compliance, as required.
• Ensure Takeda is aligned and responsive to external guidelines and regulations as they pertain to applicable regulatory requirements, i.e., oversight of creation of PSMF Annex F tables 1 and 2.
• Provide Global Labeling Compliance support for internal and external audits:
  • Ensures inspection readiness
  • Coordinates Global labeling documentation requests prior to, during and in follow up to inspections/audits
  • Provide support to Global Labeling SMEs on presentations related to global labeling processes for inspections and audits
  • Presents on global and regional labeling processes and quality to inspectors and auditors
  • Supports the development of responses and CAPAs related to global labeling for audits/inspections
  • Provides regulatory and technical expertise to manage the regulatory inspection preparation and execution processes, including development of related tools and best practices
  • Guide activities to provide a state of readiness for Health Authority inspections within Global Labeling and supporting local country (LOC) activities, including the development of strategic internal audit plans, and the execution of internal audits
• Ensures Labeling Commitments to partners and third parties are documented and tracked in the appropriate repository
• Escalate issues/problems to senior management as needed
• Provides input on budgets for the group as appropriate.
• Maintains strong knowledge of current regulations, legislation, best practices, and guidelines relating to Regulatory Affairs and labeling
• Represents Takeda at relevant Industry Forums e.g., LabelNet

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelor's degree (or equivalent) required. Masters preferred.
• 8 plus years in pharmaceutical industry, with good exposure to Regulatory Affairs, labeling, quality assurance, and/or compliance.
• Familiarity with inspections and audit procedures
• Strong knowledge of business area and interactions with strong regulatory environment and ability to identify and proactively manage the interactions necessary for achieving business goals and objectives
• Ability to identify proactively and anticipate risk of non-compliance in a complex environment
• Demonstrated knowledge of global health authorities, regulations, product approval, labeling, 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.
• 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 (TQM or Six Sigma experience preferred.
• Efficiently/actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties.
• Personnel management experience.
• Project Management abilities

Skills and Knowledge Desired:

• Systems Knowledge - extensive knowledge of Quality Management Systems, including eDMS, and Deviation (Trackwise) systems
• Regulatory Familiarity - extensive knowledge of European, US and international regulations relative to labeling
• Industry Knowledge - strong understanding of the pharmaceutical industry and pharmaceutical companies' operations processes and strategies including Regulatory Affairs processes.
• Analytical Skills - ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem.
• Communication - ability to express oneself clearly and concisely to a variety of audiences. Ability to understand/analyze/synthesize and communicate to internal/external stakeholders.
• Teamwork - Ability to work with team members in a friendly, professional manner. Motivate and empower others. Manage teams to work productively in a high-pressure environment
• Knowledge Sharing - ability to capture knowledge within (and from outside) the organization; offer solutions, improve processes and deliverables through use of information; improves information capital by contributing experience, deliverables, and models for others to use.
• Interpersonal Flexibility - ability to adapt to other personalities in a respectful manner that is conducive to goal achievement.
• 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.