Director, EUCAN Regulatory Affairs Lead, Neuroscience

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OBJECTIVE:

• Defines, develops, leads, and oversees Europe & Canada (EUCAN) Regional 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
• 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.
• Stays current and 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, 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 development of pediatric investigation plan according to EU / US requirements and with the development of orphan medicinal products for rare diseases.
• Must have experience with regulatory requirements of biological medicinal product development (monoclonal antibodies, recombinant proteins). Experience with advanced therapeutic medical products (Cell & gene therapy) will be advantageous.
• Pertinent experience with drug development in the neuroscience area highly desirable.
• Has ample experience in preparing for and leading meetings with leading health authorities including European Medicines Agency and US FDA. Able to independently manage different types of regulatory development or lifecycle management procedures in the region, including conditional approvals or rare disease approvals. Experience with managing initial MA or indication/line extension application procedures as global and/or regional lead.
• Understands the essentials of evidence requirements beyond marketing authorization (i.e. in support of patient access)
• Must be able to manage critical situations and to formulate and defend independently regional regulatory strategy to achieve competitive and accelerated product approvals.
• Thinks 'outside the box' and beyond own area of responsibility
• Is recognized as a leader in own function and within project team cross-functionally
• Has their voice heard as remote participant to global or cross functional teams; influences meeting agendas & outcomes to optimally integrate regional strategic needs
• Works with individuals and teams to set specific, measurable goals and tracks performance through a variety of formal and informal methods.

TRAVEL REQUIREMENTS:

• Willingness to travel to various meetings, including overnight trips.
• Requires approximately up to 30% travel.
• Work in flexible hours and according to Takeda's hybrid working model (office/remote)

Empowering our people to shine

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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.

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