GEM Regulatory Lead - ISEA

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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

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Solid regulatory experience, including knowledge of regulations and guidance applicable in the region across all phases of development and able to orient project teams in the interpretation of guidelines; an understanding of basic regulatory requirements in other regions globally (US, EU, emerging markets) is a plus.
•      Understands the essentials of evidence requirements beyond marketing authorization (i.e. in support of patient access/ tender requirement)
• Able to formulate regional regulatory strategy to achieve competitive and accelerated product approvals
• Experience of initial MA, indication/ line extension applications and/or lifecycle management and development submissions
• Experience with advanced therapeutic medical products (Cell & gene therapy) will be advantageous

Leadership

• Able to manage with limited supervision different types of regulatory development or lifecycle management procedures in the region in coordination with the LOC RA teams.
• Stays current with regulations / guidance in the region for impact on drug development plans, registration, and life-cycle management to maximize the positive outcomes of the regulatory applications and maintain regulatory compliance.
• Acts as an ally to support individuals as a whole and promotes an inclusive culture
• Practices active listening, encourages open dialogue, feedback, and diverse opinions
• Can speak up and is perceived as a natural, assertive authority whom peers trust for their advice

Decision-making and Autonomy

• Is able to prioritize activities and execute within reasonable time with limited supervision
• Can take some tactical decisions independently

Interaction

• Experience of participating or leading interaction with Health Authorities
• Communicates externally/with authorities in concise and respectful language
• Adapts to changing circumstances and is able to build and maintain relationships with Global teams and LOC RA and other CFTs
• Has their voice heard as remote participant to global or cross functional teams (GRT, GPT etc); influences meeting agendas & outcomes to optimally integrate regional strategic needs

Complexity

• Self-aware and able to function effectively while meeting the multiple challenges with a sense of energy, vitality, and confidence
• Develops concise strategic plans, understandably outlines the opportunities and risks of alternative scenarios before proposing a decision

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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