Associate Director, EU Regulatory Lead Neuroscience

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About the role

As the Associate Director EU Regulatory Lead Neuroscience you will define and lead regional regulatory strategies for assigned neuroscience assets supporting successful product development registration patient access and lifecycle management. You will work closely with global and regional cross-functional teams to navigate the evolving European regulatory environment drive high-quality submissions and lead interactions with Health Authorities.

How you will contribute

• Define develop and execute progressive EU regulatory strategies for assigned neuroscience assets across development and lifecycle management.

• Lead and manage regional regulatory submissions ensuring high-quality execution and timely approvals.

• Provide strategic and tactical regulatory guidance to global regional and cross-functional project teams.

• Lead Submission Working Groups and represent the EU region on global regulatory and project teams.

• Lead or support interactions with European and national Health Authorities including preparation for regulatory meetings andeffective communicationof outcomes.

• Assess emerging regulatory trends guidance and requirements and translate their potential impact into proactive regulatory strategies.

• Provide regulatory expertise across drug development registration post-marketing commitments and lifecycle management activities.

• May support value and access team in interactions with Health Technology Assessment bodies.

• Build strong relationships with local and global Regulatory Affairs teams cross-functional partners external experts and regulatory authorities.
  

What you bring to Takeda

• Bachelors degree in a scientific discipline required; advanced scientific degree highly preferred.

• Minimum 8 years of experience in drug regulatory affairs preferably with significant experience in the EU region.

• Strong knowledge of EU regulatory requirements and guidance acrossall phases ofdrug developmentand ability to orient project teams; an understanding of basic regulatory requirements in other regions globally (US Emerging markets) is a plus.

• Proven ability to develop and execute regional regulatory strategies supporting competitive and timely product approvals.

• Experience withinvestigationalregulatory submissionssuch as clinical trial applications scientific advice briefing books orphan designations paediatric plans or initialMarketing Authorisation Applications.

• Experience participating in or leading interactions with Health Authorities.

• Strong strategic thinking with the ability to assess regulatory opportunities risks and mitigation strategies.

• Excellent communication influencing and stakeholder management skills across global and cross-functional speak up and is perceived as a natural assertive authority whom peers trust for their advice.

• Fluent in English able to work independently in a complex environment and willing to travel internationally as required.

Base Salary Range:

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