Stellenbeschreibungph3Job Description /h3pbAt our heart we /b are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity, and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, sexual orientation, race, color, ethnic or social origin,or disability. /ppOur team is growing and for this we need bright minds with creativity and flexibility – bwhat talent do you have? /b /ph3About the role /h3pAt Takeda, we are a forward-looking, world-class RD organization that unlocks innovation and delivers transformative therapies to patients. By focusing RD efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life‑changing therapies to patients worldwide. /ppAs Associate Director, EUCAN Regulatory Lead – GI and Inflammation, you will lead regional regulatory strategy for assigned assets, driving submission excellence across development, registration, and life‑cycle management to enable timely patient access. You will define and communicate regulatory strategies, submission plans, and timelines, while proactively assessing regulatory risks and the impact of evolving requirements. /ph3OBJECTIVES/PURPOSE /h3ulliDefines, 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 /liliEffectively 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. /liliContributes to the development of team members and provides direction, support, mentoring, and strategic guidance to fulfil scope of project work, when applicable. /liliProvides regional tactical advice on how to achieve timely and efficient conduct of development and/or life‑cycle management of assigned product. /liliLeads the Submission Working Group and represents the region as needed on global and project teams. /liliLead interactions with health authorities in the region for an asset. /liliIn the EU: May support value and access team in their interactions with Health Technology Assessment (HTA) bodies for products within their responsibility. /li /ulh3ACCOUNTABILITIES /h3ulliDemonstrates Takeda leadership behaviors and encourages the team to live up to the Takeda Code of Conduct and leadership behaviors /liliManages, 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 /liliMay act as deputy to the Regional therapeutic area lead and/ or Regional regulatory head, attending internal leadership team meetings, as appropriate /liliMay be regulatory lead or may support a more senior regulatory lead for assigned assets and/or projects /liliEffectively 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 /liliStays 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. /liliProvides 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. /liliMay be asked to evaluate new business development opportunities and / or participate on due diligence teams /liliPrepares and maintains regulatory planning/filing documents for assigned products in the region. /liliParticipates, as appropriate, and authors/reviews internal procedures and processes. /liliUnderstands and interprets complex scientific issues for products of responsibility as it relates to regulatory requirements and strategy. /liliSupports 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 /liliDevelops effective working relationships with LOC Regulatory Lead, Regional and Global Regulatory Team, Cross- functional Teams; company’s consultants and Business Partners as required. /liliProactively builds/strengthens external stakeholder (Regulatory Agency where applicable, external experts, industry organizations, etc.) contacts/influence to achieve Takeda strategic goals and objectives /liliOversees 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 /liliLeads 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. /li /ulh3EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS /h3ulliBSc. Advanced scientific related degree preferred; BA accepted based on experience. /liliA minimum of 8 years of experience in drug regulatory affairs preferably within the EU region. /liliSolid 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. /liliUnderstands the essentials of evidence requirements beyond marketing authorisation (i.e. in support of patient access) /liliAble to formulate regional regulatory strategy to achieve competitive and accelerated product approvals /liliAble to manage with limited supervision different types of regulatory development or lifecycle management procedures in the region. /liliMay have experience with initial MA, indication/ line extension applications and/or lifecycle management and development submissions. /liliCan speak up and is perceived as a natural, assertive authority whom peers trust for their advice /liliCommunicates externally/with authorities in concise and respectful language /liliDevelops concise strategic plans, understandably outlines the opportunities and risks of alternative scenarios before proposing a decision /liliProposes risk mitigation plans /liliActs as an ally to support individuals as a whole and promotes an inclusive culture /liliPractices active listening, encourages open dialogue, feedback, and diverse opinions /liliIs able to prioritise activities and execute within reasonable time with limited supervision /liliCan take some tactical decisions /liliAdapts to changing circumstances and is able to build and maintain relationships /liliHas their voice heard as remote participant to global or cross functional teams; influences meeting agendas outcomes to optimally integrate regional strategic needs /liliReceives and gives feedback; expresses ideas, questions, and disagreement /liliIs self-aware and able to function effectively while meeting the multiple challenges of daily life with a sense of energy, vitality, and confidence /liliFluency in English /liliTRAVEL REQUIREMENTSulliRequires Willingness to travel to various meetings, including overnight trips. approximately up to 30% travel. /li /ul /liliPHYSICAL DEMANDSulliManual dexterity required to operate office equipment (i.e. computers, phones, etc.). /liliCarrying, handling, and reaching for objects. /liliAbility to sit or stand for long periods of time while traveling. /li /ul /liliWork in flexible hours /li /ulpbEmpowering our people to shine /b /ppAt 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. /ppbDiversity, Equality, and Inclusion /b /ppTakeda 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. /ppLearn more at takedajobs.com /ph3Locations /h3pZurich, Switzerland /ph3Base Salary Range /h3pCHF159,300.00 - CHF219,010.00 /ph3Worker Type /h3pEmployee /ph3Worker Sub-Type /h3pRegular /ph3Time Type /h3pFull time /p /p #J-18808-Ljbffr
