Sr. Manager, Eucan Regulatory Strategy Lead

Vor 3 Tagen

Fribourg, 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 **Sr. Manager, EUCAN Regulatory Strategy Lead** **in our Zurich office.

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

**OBJECTIVE**:

- Under supervision from a senior team member and/or Line Manager defines, develops and sometimes leads regional strategies to maximize regulatory approvals and patient access to meaningful medicines in alignment with program objectives
- Effectively communicates objective assessments of the likelihood of success of these regulatory strategies
- Provides regional strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements
- s 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 projects within the therapeutic area of responsibility
- Under supervision from a senior team member and/or Line Manager sometimes manages interactions with EMA and national health authorities (and HTAs in context of parallel consultation) in the European Region for product(s) within their responsibility.
**ACCOUNTABILITIES**:

- Ensures regional regulatory strategies are written, reviewed and executed according to plan
- In alignment with line manager, 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, plans, and executes regional regulatory submissions within the area of responsibility and ensures timely approvals throughout product development and lifecycle
- Partners with the regional market access and LOC RA 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
- Collaborates with Takeda Global and Regional counterparts and Integrated Franchise Team (IFT) to ensure the regional regulatory strategy is created and executed upon for all projects within area of responsibility
- Identifies relevant regional regulatory requirements and trends across scope of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas
- Monitors and informs on emerging trends, regulations and changes, with emphasis on those related to area and region of responsibility
- May be called upon to provide direction to senior leadership, as relevant
- Develops and maintains effective working relationships with EUCAN RA and Marketed Product Team members, LOC RA teams, Global Regulatory Teams, Cross-functional Teams; consultants and business partners as required
- Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility
In collaboration with global colleagues, works to resolve regional critical conflicts in global regulatory strategies.
- Authors and oversees execution for more complex regional regulatory strategies as needed
- Under supervision from a senior team member and/or Line Manager, sometimes leads and manages meetings and / or interactions with regulatory authorities and agency meetings; in alignment with line manager can negotiate on behalf of project team as necessary.
- Under supervision from a senior team member and/or Line Manager, sometimes represents Takeda in Health Authority meetings, as required. Effectively communicates and manages meeting outcome and next steps
- May be required to lead and provide regional regulatory input in due diligence for licensing opportunities, development and /or marketed products
- Pro-actively builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) contacts/influence to support Takeda strategic goals and objectives
- Identifies regulatory requirements across area(s) of responsibility, and provides regulatory guidance, and expertise to global development team and /or higher governance bodies in these areas
- Ensures coverage for projects within the therapeutic area identifies possible gaps, and proposes solutions to the managementPresents regional regulatory strategies to senior management as applicable
**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS**:

- BSc. Advanced scientific related degree preferred; BA accepted based on experience.Advanced degree preferred
- Considerable experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and /or post-marketing phases.
- Solid working knowledge of regulations and guidelines governing drugs and biologics

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