Group Head, Regulatory Affairs – Eastern Europe

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OBJECTIVES

Purpose of the position

The Group Head, Regulatory Affairs – Eastern Europe provides strategic and operational leadership to Takeda’s Regulatory Affairs organization across the Eastern European cluster of Local Operating Companies (LOCs). The Group Head leads the country Regulatory Affairs Heads, ensuring a single, consistent regulatory voice for the group, fully aligned with the European and global Regulatory Affairs strategy, and the effective execution of regulatory priorities across all cluster markets.

The role is accountable for building and guiding a high-performing, agile group Regulatory Affairs organization that accelerates patient access to Takeda’s innovative medicines and vaccines, safeguards regulatory compliance, and enables successful registration, commercialization and lifecycle management across a diverse set of national regulatory frameworks (EU Member States, and non-EU markets).

The Group Head represents group Regulatory Affairs towards internal and external stakeholders in a professional and competent manner and ensures that evolving regulatory requirements, health authority expectations and market needs are effectively incorporated into regional and enterprise strategies. The Group Head is a member of the Europe Regulatory Affairs Leadership Team.

Working in close partnership with the group and country business leadership, the Therapeutic Area Units, Marketed Products Development and key regional stakeholders, the Group Head ensures strong alignment between regional regulatory strategy and country-level execution, translating strategic priorities into consistent implementation across the LOC network while maintaining a unified regulatory voice for the group.

The Group Head ensures adherence to EU and national regulations as well as company guidelines, fosters a culture aligned with Takeda’s values (Takeda-ism), and drives decision-making according to Takeda’s Patient-Trust-Reputation-Business principle (P-T-R-B).

ACCOUNTABILITIES

Main responsibilities

• Provide strategic and operational leadership to the Eastern Europe Regulatory Affairs organization (LOC RA Heads / RA Leads and their teams) – setting direction, goals and standards, and ensuring optimal performance, continuous improvement and professional development.

• Translate the European and global Regulatory Affairs strategy into a group regulatory plan, ensuring a single, harmonized regulatory voice across all group affiliates and aligned with the global strategy

• Represent the group in regional regulatory strategy forums, ensuring group and country perspectives are considered in portfolio prioritization, launch sequencing and operating-model decisions.

• Ensure a consistent regulatory approach across the group in close partnership with the Therapeutic Area Units, Commerical and Marketed Products Development.

• Build and maintain effective relationships with national competent authorities across the group, relevant regional bodies and local industry associations.

• Drive harmonization of ways of working, roles and responsibilities, processes and quality standards across the group and Regulatory Affairs organization.

• Provide oversight of regulatory lifecycle management delivered through the affiliates across the group portfolio – marketing authorization applications (centralized, MRP/DCP, national procedures), variations, renewals, labeling and product information – ensuring timeliness, quality and compliance.

• Ensure regulatory compliance across the group and maintain audit and inspection readiness in accordance with EU, national legislation and internal guidelines.

• Partner with cluster and country business leadership, Medical Affairs, Market Access, MCE, Pharmacovigilance, Quality and Supply Chain to enable successful product launches, life-cycle management, continuity of supply and patient access, aligned with commercial priorities.

• Lead regulatory intelligence for the group: anticipate and assess changes in the national and regional regulatory environment (e.g. EU pharmaceutical legislation revision, HTA Regulation / Joint Clinical Assessment, local pricing and reimbursement linkages) and translate implications into regulatory strategies, risk mitigation plans and business recommendations.

• Attract, develop and retain regulatory talent; build capability, succession and engagement across the group RA organization.

• Plan and manage the group Regulatory Affairs budget and resources in coordination with Finance and functional leadership.

• Establish governance, key performance indicators for the group RA organization, reporting into the Europe Regulatory Affairs leadership in alignment with International RA approach.

Additional responsibilities – group & regional leadership

• Serve as a member of the Europe Regulatory Affairs Leadership Team and act as escalation point for significant regulatory risks and issues arising in the group.

• Sponsor and lead group regulatory transformation and operating-model initiatives (e.g. LOC integration, simplification and harmonization of the group RA model).

• Provide regulatory support and oversight to markets served through distributors or partner arrangements within the group, where applicable.

• Represent Takeda in relevant national and cross-industry regulatory initiatives and external engagements within the group.

• Ensure the group organization operates in compliance with Takeda’s values and all applicable ethics and compliance requirements.

SCOPE OF SUPERVISION

The role leads a multi-country Eastern European Regulatory Affairs organization through a team of country Regulatory Affairs Heads / Leads (direct reports), with broader indirect oversight of the LOC RA teams. Group scope: [Poland, Czech Republic, Slovakia, Hungary, Romania, Bulgaria, Croatia, Slovenia, Bosnia Herzegovina, Serbia, Baltics].

NUMBER OF SUPERVISED WORKERS

Direct: 8

In-Direct: ca. 30

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

Functional initial education

• Advanced degree (PhD, PharmD, MD, MSc or equivalent) in pharmacy, life / natural sciences, medicine or a related discipline.

Functional further education and additional training

• Solid expertise in the European regulatory framework (EMA, centralized procedure, MRP/DCP and national procedures) and in national requirements of the group markets.

• Proven leadership training and experience in people and organizational management.

• Continuous professional development in regulatory affairs, legislation and internal guidelines.

Necessary experience

• 10+ years of progressive Regulatory Affairs experience in the pharmaceutical / biopharmaceutical industry, including substantial experience in the Eastern European environment.

• 5+ years of leadership experience managing multi-country or group teams, ideally across affiliate / LOC organizations.

• Demonstrated track record of engagement with national competent authorities and of contributing to regional regulatory strategy.

• Experience leading through a matrix and driving change across a complex, multi-cultural organization.

Behavioural competencies and skills

• Strategic thinking, enterprise mindset and the ability to influence at senior levels internally and externally.

• Strong stakeholder management, communication and leadership presence.

• Ability to build, align and inspire high-performing teams across cultures and geographies.

• Sound understanding of the evolving EU and non-EU regulatory landscape and its business implications.

• Excellent written and spoken English; additional languages of the group an advantage.

LICENSES / CERTIFICATIONS

Not Applicable

PHYSICAL DEMANDS

Not applicable.

TRAVEL REQUIREMENTS

Regular travel across the group affiliates and to regional / global functional meetings (approximately 20%).

Compensation: The salary range displayed reflects the primary location associated with this posting. Compensation may vary for candidates considered in other locations. Where applicable, location-specific salary ranges and compensation information will be provided in accordance with local requirements.

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.

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