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Regulatory Affairs Expert

2 weeks ago

Dubai, Dubai, United Arab Emirates Takeda Full time

As a key member of the Takeda team, you will play a crucial role in defining and implementing area regulatory strategies to maximize regulatory success and enable patient access to innovative treatments.

Key Responsibilities
  • Develop and lead area regulatory strategies, working closely with line management and Country RA Heads to ensure timely approval of investigational drugs, marketing authorizations, and life-cycle management submissions.
  • Effectively communicate regulatory strategies, submission plans, and timelines to stakeholders, including Global Product Teams, Health Authorities, and cross-functional teams.
  • Liaise with global regulatory teams to represent GEM RA strategies and provide strategic and tactical advice to leadership teams on regulatory requirements and compliance.
  • Lead Submission Working Groups for submissions in the area and represent the area on global and project teams for new product approvals.
  • Manage interactions with Health Authorities in collaboration with Area stakeholders and LOC RA teams, ensuring compliance with applicable regulations and guidelines.
  • Evaluate new business development opportunities and participate in due diligence teams to identify potential growth areas.
  • Act as Deputy of RA Area Head and support RA activities for other areas as needed, demonstrating strong leadership and problem-solving skills.
Requirements
  • Demonstrate solid regulatory experience, including knowledge of regulations and guidance applicable in the region across all phases of development.
  • Understand the essentials of evidence requirements beyond marketing authorization, including patient access and tender requirements.
  • Able to formulate regional regulatory strategy to achieve competitive and accelerated product approvals, staying current with regulations and guidelines in the region.
  • Prior experience in drug regulatory affairs, preferably within the EU/GEM region, is essential, along with a minimum of 8 years of experience in this field.
  • Receives and gives feedback, expresses ideas, questions, and disagreement, and fluency in English and other local languages is an advantage.
Working Environment

This role offers a dynamic and challenging environment, requiring strong communication and interpersonal skills, with opportunities to grow and develop your career within Takeda's Regulatory Affairs team.

What We Offer

Takeda offers a competitive compensation package, flexible work arrangements, and opportunities for professional growth and development, in a collaborative and inclusive work environment.