GEM Regulatory Leads - TAS

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Job Description

OBJECTIVES/PURPOSE

• Defines, develops, and leads area regulatory strategies, in close alignment with line management and Country (LOC) RA Heads, to maximize regulatory success and enabling patient access, including all aspects of submission and timely approval of investigational drugs, marketing authorizations and life-cycle management submissions and subsequent Q&As from authorities. “
• Effectively communicates (including Global Product Team (GPT) representation when relevant) the regulatory strategies, submission plans and timelines; assessment of the likelihood of success of regulatory strategies and impact assessments of trends, regulations and changes related to assigned programs.  
• Liaise with cross functional stakeholders including  Global Regulatory Teams (GRT) to represent GEM RA strategies
• Additionally may act as GEM RA Lead for one or more assets for entire GEM region covering from      development to the life cycle maintenance activities.
• Provides strategic and tactical advice, guidance and area regulatory expertise to global leadership teams on how to achieve timely and efficient conduct of development and/or life-cycle management of assigned programs while maintaining full compliance with applicable regulatory requirements
• Leads the Submission Working Group (SWG) for submissions in the area and represents the area as needed on global and project teams for the new Mas & other major submissions
• Manages or supports and oversees interactions with Health Authorities in the  Area in collaboration with Area stakeholders and LOC RA teams
• May support value and access team in their interactions with Health Authorities  for negotiations related to  products within their responsibility (wherever applicable) – For specific areas only
• Evaluates new business development opportunities and / or participates in due diligence teams
• May act as Deputy of RA Area Head and may support RA activities for other areas as needed

ACCOUNTABILITIES

• Demonstrates Takeda leadership behaviors at all times  (for external need HR support to briefly highlight Takeda leadership behaviours requirements)
• Independently manages, plans, and works closely with Regional, LOC Regulatory Leads, BU Cross-functional Teams (CFT), and Global Regulatory Teams to deliver all aspects of regulatory activities throughout the product life cycle in close partnership with Global Regulatory TA Leadership and aim for a successful and timely outcome of RA applications in the area
• Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility
• Accountable for communications to the regulator, development teams, and GRA, other Research and Development (R&D) functions, and TAU leadership.
• Provides regulatory expertise on drug development, registration and / or post-marketing compliance and life cycle management.
• Participates, as appropriate, and authors/reviews internal procedures and processes.
• Understands and interprets complex scientific issues for products of responsibility as it relates to regulatory requirements and strategy.
• Develops effective working relationships with LOC Regulatory Lead, Regional and Global Regulatory Team, cross- functional commercial Area & LOC Teams; company’s consultants and Business Partners as required.
• Actively pursues or oversees the tracking and fulfillment of post- marketing commitments.
• Presents regional regulatory strategies to leadership/senior management and shall be able to identify and share the risks and opportunities as well as probability of success of proposed strategy

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• BSc. Advanced scientific related degree preferred; BA accepted based on experience.
• A minimum of 8 years of experience in drug regulatory affairs preferably within the EU/GEM region.
• Prior experience of ‘area’/ countries  will be an advantage
• Receives and gives feedback; expresses ideas, questions, and disagreement
• Fluency in English and other local languages will be an advantage
• Work in flexible hours

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