Director/associate Director, Eu Regulatory Lead

Vor 2 Tagen

Zurich, Schweiz Takeda Pharmaceutical Vollzeit

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a **Director/Associate Director, EU Regulatory Lead - Rare Genetic & Hematology** in our **Zurich **office.

**Here, you will be a vital contributor to our inspiring, bold mission.**

**Objective**:

- Defines, develops and manages regional strategies to maximize regulatory approvals and patient access to meaningful medicines in alignment with program objectives. Effectively conveys assessments of the likelihood of success of these regulatory strategies.
- Manage the Regional Working Team and represents the region as needed on global and project teams. Provides regional regulatory expertise for assigned development and/or life cycle management project(s).
- Manage the Regional Working Team and represents the region as needed on global and project teams. Provides regional regulatory expertise for assigned development and/or life cycle management project(s).

**Accountabilities:
**- Ensures regional regulatory strategies are written, reviewed and executed according to plan. Authors and oversees execution for more complex regional regulatory strategies as needed.
- Provides strategic and tactical advice and guidance to allow the timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements
- Manages regional regulatory submissions and ensures timely approvals throughout product development and lifecycle.
- Partners with the regional market access and local regulatory colleagues to define the strategy for, and to lead and oversee joint interactions with regional and national regulatory/health agency/HTA bodies on value and evidence topics and to support heath authority decision making.
- Partners with Takeda Global and Regional counterparts and Integrated Franchise Team to ensure the regional regulatory strategy is created and executed upon for all projects.
- Identifies regulatory requirements and trend, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas
- Mentors team members, if necessary.
- Act as deputy to the Regional therapeutic area Head and/ or Regional regulatory head, attending internal management team meetings, as needed.
- Monitors and informs on emerging trends, regulations and changes, with emphasis on those related to area and region of responsibility. Provides direction to senior leadership, as relevant
- Develops and maintains effective working relationships with EUCAN RA and Rare Genetic & Hematology team members, local RA teams, Global Regulatory Teams, Cross-functional Teams; consultants and business partners as needed.
- Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule.- In partnership with global colleagues, works to resolve regional critical conflicts in global regulatory strategies
- Leads and manages meetings and/ or interactions with regulatory authorities and agency meetings; negotiates on behalf of project team as necessary. Represents Takeda in Health Authority meetings, as needed. Effectively

communicates and manages meeting outcome and next steps
- Lead and provide regional regulatory input in due diligence for licensing opportunities, development and /or marketed products.
- Proactively builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) relationship to achieve Takeda strategic goals and objectives.
- Identifies regulatory requirements and trends and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas, as requested
- Ensures coverage for projects, identifies possible gaps, and proposes solutions to the management
- Presents regional regulatory strategies to senior management as applicable.

**Education, Competencies and Skills:
**- BSc. Advanced science-related degree is preferred; BA accepted based on
experience.
- 8-10 years of pharmaceutical industry background including 6-8 years

of regulatory experience or a solid combination of regulatory and/or related
experience in both development and /or post-marketing phases.
- Solid working knowledge of regulations and guidelines governing drugs and biologics in all phases of development, including post-marketing, in the EU, with a good knowledge of basic regulatory requirements in emerging markets. Knowledge of evidence requirements beyond the regulators (e.g. HTA bodies).
- Ability to interpret complex scientific issues as it relates to regulatory
requirements and strategy
- Preferred experience in managing multiple filings; or managing multiple programs in closely related development area; expertise in the EU region with global involvement is also preferred.
- Generally strong in all basic skill sets such as oral and written communications, managing and

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