- Establishes, implements and monitors systems to ensure regulatory compliance worldwide.
- Determines and oversees global regulatory operational strategy and submission activities for the Vaccine Business Unit resulting in high quality submissions.
- Working across VBU program teams, leads the approach to vaccine labeling based on enterprise thinking, global compliance and system submission requirements.
- Provide strategic vision and leadership to develop, create and implement global harmonized submission assembly processes to support VBU business objectives and to enable optimal utilization of global resources and tools.
- Develop portfolio and capacity forecasts through partnership with global peers and stakeholders and oversee global dossier planning through effective use of document management and workflow tools.
- Interact with trade organizations and industry groups to identify regulatory trends and policies that could affect VBU.
- Accountable for the development, approval, and implementation of document management, workflow, and submission tools to support VBU business objectives.
- Accountable for oversight of regulatory compliance, as assigned (for example, tracking of commitments; leading RAV SOP oversight; managing RAV training, working across departments in support of regulated systems, managing regulatory audits and inspections)
- Create and implement strategies to ensure establishment and compliance with guidances, as appropriate, so that the company regulatory documents are acceptable to global regulatory agencies. Maintain awareness of new regulatory guidances and interpret into system or process changes, as appropriate.
- Partner with existing Takeda resources or external resources to ensure the timely compilation, publication and distribution of valid electronic and/or paper submissions according to specific country requirements for the registration of products to health authorities worldwide.
- Identify, assess, communicate and mitigate risk associated with submissions.
- Encourage continuous improvement through capture of learnings and develop, maintain and implement plans and process to handle and respond to change management needs within regulatory submissions.
- Define planning and document tracking to support timely submission.
- Partner with Project Management and Regional Regulatory Heads to ensure that planning is complimentary; key dates are kept consistent and appropriate information is exchanged.
- Ensure that input, direction and consultation regarding EDMS (electronic data management system) on vision and strategy for the evolution of technology and processes to support VBU business needs and meet evolving global electronic submission requirements is provided to all relevant stakeholders.
- Influence document management system strategies and system evolution to permit the automation and harmonization of global submission management and tracking processes, reducing manual and/or duplicate data entry.
- Responsible for the budget associated with regulatory operations.
- As assigned, manage/develop/hire vaccine regulatory operational staff.
EDUCATION, EXPERIENCE AND SKILLS:
- BS degree or equivalent in a scientific discipline; advanced degree preferred
- 15 years pharmaceutical or related industry experience
- 10 years of document management including labeling and quality oversight
- 5 years of requirements experience in building document manage systems
- Previous management experience
- Excellent interpersonal, mentoring and leadership skills
- Adept at exhibiting cross-cultural awareness and working in a global environment
- Strong in all basic skills sets such as oral and written communication across all levels of the organization, managing and adhering to timelines, negotiation skills, integrity and adaptability
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Ability to sit and stand for long periods of time
- Carrying, handling and reaching for objects
- Ability to lift and carry over 25 pounds
- Manual dexterity to operate office equipment i.e. computers, phones, etc.
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