Associate Director, EU Regulatory Lead Neuroscience

CHE - 8036 Takeda Pharmaceuticals International AG; Glattbrugg; Vor Ort; CHF 159.000 - 219.000; Vollzeit

Zusammenfassung

Takeda Pharmaceuticals International AG in Zurich seeks an Associate Director, EU Regulatory Lead Neuroscience to define and lead regional regulatory strategies for neuroscience assets, supporting development, registration, patient access and lifecycle management. You will collaborate with global and regional teams to navigate EU regulatory requirements, drive high-quality submissions and lead interactions with Health Authorities.

Travel international as required.

Qualifikationen

• Requires minimum of 8 years in drug regulatory affairs, with significant EU experience.
• Strong knowledge of EU regulatory requirements across development and lifecycle.
• Proven ability to lead regional regulatory strategies and submissions.

Aufgaben

• Define, develop and execute progressive EU regulatory strategies for neuroscience assets.
• Lead regional regulatory submissions and ensure timely approvals.
• Provide regulatory guidance to global, regional and cross-functional teams.
• Lead or support interactions with Health Authorities and regulatory meetings.

Kenntnisse

EU regulatory knowledge

Regulatory submissions

Stakeholder management

English fluency

Travel readiness

Ausbildung

Bachelor's degree

Advanced scientific degree preferred

Jobbeschreibung

Job Description

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 and Salary

Locations Zurich, Switzerland

Base Salary Range: CHF159,300.00 - CHF219,010.00

Working Hours and Contract Type

Worker Type Employee Worker Sub-Type Regular Time Type Full time

About Takeda

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

Equal Opportunity Employer

Takeda is an equal opportunity employer.