Requirements: English
Company: WhatJobs
Region: Zrich , Zurich
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
OBJECTIVES/PURPOSE:
- Defines, develops, and leads Regional regulatory strategies in close alignment with line management to maximize regulatory success to strengthen the product development plan, in support of enabling patient access. This includes all aspects of submission and timely approval of investigational applications, market application and life-cycle management.
- Effectively communicates the regional regulatory strategies, submission plans and timelines, assesses the likelihood of success of the regional regulatory strategies and impact of trends, regulations and changes related to assigned asset.
- Contributes to the development of team members and provides direction, support, mentoring, and strategic guidance to fulfil scope of project work, when applicable.
- Provides regional tactical advice on how to achieve timely and efficient conduct of development and/or life-cycle management of assigned product.
- Leads the Submission Working Group and represents the region as needed on global and project teams.
- Leads interactions with health authorities in the region for an asset.
- In the EU: May support value and access team in their interactions with Health Technology Assessment (HTA) bodies for products within their responsibility.
ACCOUNTABILITIES:
- Demonstrates Takeda leadership behaviors and encourages the team to live up to the Takeda Code of Conduct and leadership behaviors.
- Manages, plans, and executes regional regulatory submissions in close alignment and ensures timely approvals throughout product development and lifecycle, in close collaboration with Regional, LOC Regulatory Leads, BU Cross-functional Teams, and Global Regulatory Teams.
- May act as deputy to the Regional therapeutic area lead and/or Regional regulatory head, attending internal leadership team meetings, as appropriate.
- May be regulatory lead or may support a more senior regulatory lead for assigned assets and/or projects.
- Effectively communicates the regulatory strategies, submission plans and timelines, probability of success, and impact assessments related to assigned programs and presents regional regulatory strategies to leadership/senior management.
- Stays current with regulations/guidance in the region and, in coordination with local regulatory leads and Global Regulatory Policy & Innovation, provides strategic advice on emerging trends, regulations, and changes, with emphasis on those related to assigned program enabling proactive approach and planning to future business needs.
- Provides regulatory expertise on drug development, registration and/or post-marketing compliance and life cycle management.
- May be asked to evaluate new business development opportunities and/or participate on due diligence teams.
- Prepares and maintains regulatory planning/filing documents for assigned products in the region.
- Participates, as appropriate, and authors/reviews internal procedures and processes.
- Actively pursues the tracking and fulfillment of post marketing commitments.
- Understands and interprets complex scientific issues for products of responsibility as it relates to regulatory requirements and strategy.
- Supports Access to Medicines initiatives to develop and implement innovative patient access strategies.
- Develops effective working relationships with LOC Regulatory Lead, Regional and Global Regulatory Team, Cross-functional Teams; companys 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.
- Oversees and is 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. May oversee vendor staff.
- Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications as needed.
- Leads or supports preparation activities for meetings with Health Authorities for the assigned program, as required.
- Oversees LOC interactions with Health Authorities for responsible programs.
- Interacts directly with HA (EUCAN), as required. Represents Takeda in Health Authority meetings, as required. Effectively communicates an