Associate Director, EU Regulatory Lead Neuroscience

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Job Description

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 and effective communication of 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

• Bachelor’s 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 across all phases of drug development and 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 with investigational regulatory submissions, such as clinical trial applications, scientific advice briefing books, orphan designations,  paediatric plans, or initial Marketing 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 teams. Can 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.

Locations

Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

For information about our benefits, please click here.

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