Takeda is seeking a seasoned GEM Regulatory Lead to drive regulatory strategies across the EAMEA region, supporting new drug approvals, lifecycle management, and regulatory compliance. This full-time Dubai-based position plays a critical role in enabling patient access and ensuring timely and successful interactions with Health Authorities.

Key Responsibilities:

• Define and execute regional regulatory strategies for investigational and marketed products.

• Collaborate with Global and Country Regulatory Affairs teams and cross-functional stakeholders.

• Serve as GEM RA Lead for one or more assets across their entire lifecycle.

• Lead submission working groups and contribute to global and regional submission planning.

• Manage regulatory interactions and communications with Health Authorities.

• Support product access initiatives, compliance activities, and post-marketing commitments.

• Evaluate new business development opportunities and contribute to due diligence.

Qualifications & Skills:

• Bachelor’s degree in Science, Pharmacy or related field; Advanced degree preferred.

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

• Strong knowledge of regional and international regulatory guidelines.

• Proven experience with MAAs, line extensions, and lifecycle management.

• Exceptional interpersonal, communication, and leadership skills.

• Fluent in English; additional languages are a plus.

• Able to work flexible hours and operate autonomously with cross-cultural teams.

• Experience with advanced therapies (cell/gene therapy) is an advantage.

Why Join Takeda:

• Join a global pharmaceutical leader with a strong focus on innovation and ethics.

• Contribute to regulatory excellence across emerging markets.

• Enjoy professional growth in a diverse, inclusive, and forward-thinking environment.

• Be part of a mission-driven organization committed to improving health worldwide.

Application Process:
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