Director, Eucan Regulatory Affairs Lead

vor 5 Monaten

Zurich, Schweiz Takeda Pharmaceutical Vollzeit

Our team is growing and for this we need bright minds with creativity and flexibility - **what talent do you have?**

**OBJECTIVE**:

- Effectively communicates the regulatory strategies, submission plans and timelines; assessment of the likelihood of success of the regulatory strategies and impact assessments of trends, regulations and changes related to assigned programs.
- Provides strategic and tactical advice and guidance and regional regulatory expertise to regional and global leadership teams on how to achieve timely and efficient conduct of all development and/or life-cycle management programs pertaining to the Therapeutic Area, while maintaining full compliance with applicable regulatory requirements
- Leads the Submission Working Group for submissions in the region and represents the region as needed on global and project teams.
- Manages/supports and oversees interactions with health authorities in the region
- Supports value and access team in their interactions with Health Technology Assessment (HTA) bodies for products within their responsibility.
- May act as the (deputy) Regional RA Therapeutic Area (TA) Team Lead.
- May provide leadership, mentoring and strategic guidance to regulatory strategists.

**ACCOUNTABILITIES**:

- Demonstrates Takeda leadership behaviors and encourages the team to live up to the Takeda Code of Conduct and leadership behaviors. Develops capabilities of staff members.
- Independently manages, plans, and works closely with Regional, LOC Regulatory Leads, BU Cross-functional Teams, and Global Regulatory Teams to direct all aspects of regulatory activities throughout the product life cycle.
- Presents regional regulatory strategies to leadership/senior management.
- Provides regulatory expertise to senior management on drug development, registration and / or post-marketing compliance and life cycle management.
- Evaluates new business development opportunities and / or participates on due diligence teams
- In coordination with local regulatory leads and Global Regulatory Policy & Innovation, provides strategic advice on emerging trends and regulations, and changes, with emphasis on those related to assigned program enabling proactive approach and planning to future business needs.
- Actively pursues or oversees the tracking and fulfillment of post marketing commitments.
- Understands and interprets complex scientific issues across projects and therapeutic area(s) of responsibility as it relates to regulatory requirements and strategy.
- Supports Access to Medicines initiatives to develop and implement innovative patient access strategies
- Drives the development of effective working relationships with LOC Regulatory Lead, Regional and Global Regulatory Team, Cross
- functional Teams; company’s consultants and Business Partners as required.
- Proactively builds/strengthens external stakeholder (Regulatory Agency where applicable, external experts, industry organizations, etc.) contacts/influence to achieve Takeda strategic goals and objectives
- Effectively communicates the regulatory strategies, submission plans and timelines, probability of success, and impact assessments of trends, regulations and changes related to assigned programs.
- 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
- Understands the importance and oversees regulatory dossiers for value and access strategies and encourages the design of an integrated regulatory submission & access strategy in partnership with access functions as needed
- Leads, oversees and ensures preparation activities for meetings with Health Authorities for the assigned program, as required.
- Interacts directly with Health Authority and represents Takeda in Health Authority meetings, as required. Effectively communicates and manages meeting outcome and next steps
- Independently leads meetings and / or interactions with regional regulatory authorities or (in conjunction with LOC) national authorities and negotiates on behalf of project team as necessary.
- Contributes to ensure coverage for projects within the therapeutic area, identifies possible gaps, and proposes solutions to the management.

**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS**:

- BSc. Advanced scientific related degree with Regulatory Affairs focus preferred.
- A minimum of 10-15 years of experience in drug regulatory affairs including in global regulatory role and in Europe/International region.
- Solid regulatory experience, including knowledge of regulations and guidance applicable in the region across all phases of drug development and with the management of post-approval obligations and able to independently orient project teams in the interpretation of guidelines; including a good understanding of regulatory requirements globally and in other regions (US, EU, Emerging markets).
- Must have experience with the developme

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