EUCAN Regulatory Therapeutic Area Team Lead – Oncology (Executive Director)
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OBJECTIVES/PURPOSE
As the EUCAN (Europe & Canada) Regulatory Therapeutic Area Team Lead for Oncology, oversees and directs all regulatory activities related to oncology products.
Provides strategic leadership and oversight to a team of regulatory strategists who define, develop, and lead Europe & Canada (EUCAN) regulatory strategies to maximize regulatory success to strengthen the product development plan in support of enabling patient access, including all aspects of submission and timely approval of investigational applications, market application and life-cycle management.
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
Ensures that staff members stay current with regulations / guidance in the region for impact on drug development plans, registration, and life-cycle management to maximize the positive outcomes of the regulatory applications and maintain regulatory compliance.
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 regulatory experience, including knowledge of regulations and guidance applicable in the region governing drugs and biologics in all phases of development; preferred is a good understanding of regulatory requirements in other regions globally (US, EU, Emerging markets). Experience leading interaction with Health Authorities.
Excellent communication and interpersonal skills, with the ability to influence and collaborate effectively.
Must be able to provide guidance in interpreting regulatory regulations and guidelines. Must be able to formulate Regional regulatory strategy to achieve competitive and accelerated product approvals.
Strategic thinker with exceptional problem-solving and decision-making capabilities, yet is flexible to adapt to changing priorities and deadlines in a dynamic environment.
Provides oversight of regulatory strategy for development and lifecycle management products in oncology in EUCAN region. Experience with managing EU initial MA or indication/ extension application procedures or global involvement is required. Experience in managing multiple filings; or multiple programs including global involvement.
Builds and maintains strong trusting relationships with regulators and other stakeholders. Has several years’ experience in managing direct reports.
Is recognized as a leader cross functionally in the organization and externally.
Strong leadership and people management skills, with the ability to mentor and develop a high-performing team.
Creates a clear and unifying vision that inspires the team to excel and understand the connection between their work and the organization’s purpose.
Fosters a climate that encourages open dialogue, feedback, and diverse opinions; balances direction and support with empowerment.
Empowering our people to shine
At Takeda, we earn the trust of society and our customers through our values of Takeda-ism: Integrity, Fairness, Honesty, Perseverance. We incorporate these values in everything we do. They represent who we are and how we act. They help us make decisions that we can be proud of today and in the future. We enable our employees to develop their full potential. As a global top employer, we offer exciting career paths, promote innovation, and strive for top performance in everything we do. Takeda fosters an inclusive, collaborative, and international work environment where our teams are united by their relentless commitment to our goal of improving people's health and creating a better future for the world.
Diversity, Equality, and Inclusion
Takeda is committed to foster diversity, equality, and inclusion. Hiring decisions are based entirely on qualifications and are made regardless of gender, ethnic origin, religion, sexual orientation, age, or disability.
If you are interested in this opportunity, we look forward to receiving your application via our online tool!
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