GEM Regulatory Leads - SAM

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Job Description

The Regulatory Affairs, Associate Director ensures we gain regulatory approval for new products and product amendments, while maintaining the currency of product licenses and permits. You will help Takeda navigate and comply with legislation and regulations, supporting our mission to bring better health to people and a brighter future to the world.

GOALS/PURPOSE

• Define, develops, and leads area regulatory strategies, in close alignment with line management and Country (LOC) RA Heads, to maximize regulatory success and allowing 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.

• Partner with cross functional stakeholders including Global Regulatory Teams (GRT) to represent GEM RA strategies

• Be GEM RA Lead for one or more assets for entire GEM region covering from development to the life cycle maintenance activities.

• Provide strategic and tactical advice, guidance and area regulatory expertise to global leadership teams on how to achieve efficient conduct of development or life-cycle management of assigned programs while maintaining full compliance with applicable regulatory requirements

• Lead the Submission Working Group (SWG) for submissions in the area and represent the area as needed on global and project teams for the new Mas & other major submissions

• Manage or support and oversees interactions with Health Authorities in the Area in collaboration with Area team members 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

• Evaluate 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

ACCOUNTABILITIES

• Demonstrate Takeda leadership behaviors (for external need HR support to briefly highlight Takeda leadership behaviours requirements)

• Independently manage, 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

• Oversee and accountable for working with other RA functions or vendor to ensure that regulatory submissions and approvals are achieved within your responsibilities

• Accountable for communications to the regulator, development teams, and GRA, other Research and Development (R&D) functions, and TAU leadership.

• Provide regulatory expertise on drug development, registration or post-marketing compliance and life cycle management.

• Participate, as appropriate, and authors/reviews internal procedures and processes.

• Understand and interpret complex scientific issues for products of responsibility as it relates to regulatory requirements and strategy.

• Develop effective working relationships with LOC Regulatory Lead, Regional and Global Regulatory Team, cross- functional commercial Area & LOC Teams; our consultants and Partners as required.

• Pursues or oversees the tracking and fulfillment of post- marketing commitments.

• Present regional regulatory strategies to leadership/senior management and shall be able to identify and share the risks and opportunities and probability of success of proposed strategy

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• BSc. Advanced scientific related degree, BA accepted based on experience.

• 8 years + of experience in drug regulatory affairs preferably within the EU/GEM region.

• Prior experience of 'area'/ countries will be an advantage

• Receive and give feedback; express ideas, questions, and disagreement

• Fluency in English and other local languages will be an advantage

• Work in flexible hours

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