Senior EU Regulatory Lead GI&I / Director

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We are looking for a dedicated Senior EU Regulatory Lead GI&I, Director.

OBJECTIVES/PURPOSE

• Defines, develops, and leads Regional (progressive 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.
• May act as the (deputy) Regional RA Therapeutic Area (TA) Team Lead. 
• 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.
• Lead 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 behaviours and encourages the team to live up to the Takeda Code of Conduct and leadership behaviours. Develops capabilities of staff members. 
• 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
• Effectively communicates the regulatory strategies, submission plans and timelines, probability of success, and impact assessments 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 and actively pursues the tracking and fulfillment of post marketing commitments.
• 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. 
• 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. Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications as needed  
• Develops 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
• 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 
• Leads and manages meetings and / or interactions with regional regulatory authorities or (in conjunction with LOC) national authorities with minimal supervision and negotiates on behalf of project team as necessary. Represents Takeda in Health Authority meetings, as required and effectively communicates and manages meeting outcome and next steps. Leads or supports preparation activities for meetings with Health Authorities.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• BSc. Advanced scientific related degree preferred; BA accepted based on experience.
• A minimum of 10 years of experience in drug regulatory affairs preferably within the EU/GEM region.
• 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 across all phases of development and able to orient project teams in the interpretation of guidelines; an understanding of basic regulatory requirements in other regions globally (US, EU, Emerging markets) is a plus. Experience participating to or leading interaction with Health Authorities.
• Understands the essentials of evidence requirements beyond marketing authorisation (i.e. in support of patient access)
• Able to formulate regional regulatory strategy to achieve competitive and accelerated product approvals
• 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.
• Has amble experience with initial MA, indication/ line extension applications and/or lifecycle management and development submissions.
• Can speak up and is perceived as a natural, assertive authority whom peers trust for their advice
• Communicates externally/with authorities in concise and respectful language
• Develops concise strategic plans, understandably outlines the opportunities and risks of alternative scenarios before proposing a decision
• Proposes risk mitigation plans
• Delivers on priorities, identifies activities that could be delegated, clearly describes expectations, and empowers people that are carrying out delegated activities while maintaining oversight
• Involves the right stakeholders into decision-making, manages internal negotiations and identifies areas of improvement
• Takes decisions within their remit effectively and ensures stakeholders are aware
• Delivers on priorities, identifies activities that could be delegated, clearly describes expectations, and empowers people that are carrying out delegated activities while maintaining oversight
• Involves the right stakeholders into decision-making, manages internal negotiations and identifies areas of improvement
• Takes decisions within their remit effectively and ensures stakeholders are aware
• 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.
• Provides opportunities to develop others’ technical/functional skills and behaviors and monitors progress toward achieving development goals.
• Fluency in English

TRAVEL REQUIREMENTS

•        Requires Willingness to travel to various meetings, including overnight trips. approximately up to 30% travel.

PHYSICAL DEMANDS

•        Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).

•        Carrying, handling, and reaching for objects.

•        Ability to sit or stand for long periods of time while traveling.

•        Work in flexible hours 

Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

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