Eucan Regulatory Therapeutic Area Team Lead
vor 1 Tag
Our team is growing and for this we need bright minds with creativity and flexibility - **what talent do you have?**
**_ OBJECTIVES/PURPOSE _**
As the EUCAN (Europe & Canada) Regulatory Therapeutic Area Team Lead for Oncology, oversees and directs all regulatory activities related to oncology products.
- Ensures recruitment, line management and development of direct reports; provides direction, support, mentoring, and strategic guidance to fulfil scope of project work, when applicable. May act as Regional RA Therapeutic Area (TA) Team Lead or deputy Regional Head/VP.
- 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 oncology, while maintaining full compliance with applicable regulatory requirements.
- Ensures team resourcing and appointment of appropriately skilled EUCAN Regulatory Leads to Global Regulatory Teams and Submission Working Groups.
- Manages or supports and oversees health authorities interactions in the region and key external stakeholder management. 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. Develops capabilities of staff members.
- Ensures the planning and management of all regulatory activities throughout the product life cycle, for the Therapeutic Area portfolio in close partnership with Global Regulatory TA Leadership, Regional cross-functional teams, and LOC management.
- May act as deputy to the Regional therapeutic area lead and/ or Regional regulatory head, attending internal leadership team meetings, as appropriate.
- 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
- Oversees and ensures 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 stakeholders (Regulatory Agency, external experts, industry organizations, etc.) 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.
- 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 across the business portfolio.
- Interacts directly or oversees with HA (EUCAN), as required. Represents Takeda in Health Authority meetings that may have critical impact on overall strategy or Takeda reputation; may negotiate on behalf of project team, as necessary.
- Ensures coverage for projects within the therapeutic area, identifies possible gaps, and proposes solutions to the management.
- Works closely with cross-functional teams to ensure regional regulatory considerations are integrated into global development plans.
- Identifies regulatory risks and develops mitigation strategies to support successful product approvals and lifecycle management.
- Drives innovation in regulatory process improvements, including the use of advanced technologies and methodologies to enhance submission quality and efficiency.
- Leads and provides regional regulatory input in due diligence for licensing opportunities, development and /or marketed products.
**_ EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:_**
- BSc. Advanced scientific related degree preferred.
- A minimum of 15 years of regulatory affairs experience in the pharmaceutical/biotechnology industry within the EU region
- Comprehensive knowledge of regional regulatory requirements and guidelines for oncology products.
- Proven track record of successful regulatory submissions and approvals for oncology products.
- Experience with advanced therapeutic medical products (Cell & gene therapy) will be advantageous.
- Solid r
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