\\n By clicking the \\xe2\\x80\\x9cApply\\xe2\\x80\\x9d button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda\\xe2\\x80\\x99s and . I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

At our heart we 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.

Our team is growing and for this we need bright minds with creativity and flexibility \\xe2\\x80\\x93 what talent do you have?

OBJECTIVES/PURPOSE

Provides strategic and tactical advice to internal and external teams to achieve timely and efficient maintenance of programs, while ensuring compliance with applicable regulatory requirements

Partners with internal stakeholders and external vendor partners such as GPSE, Global Labeling, Global CMC, Local Operating Companies and Supply Chain on matters related to MPD (Marketed Products Development) EPIC portfolio

Ensures successful and effective oversight of the vendor management model by defining the strategy, overseeing regulatory activities for designated portfolio of products, and resolving and escalating issues as necessary

Is a leader both internally and externally, contributing to cross-functional initiatives and influencing the field as applicable

Responsible for providing support and assistance to the Director, GRA MPD, EPIC Lead with leadership and oversight for all strategically sourced activities related to portfolio

Primary point of contact for a designated portfolio of products that are vendor managed

ACCOUNTABILITIES

Supports an outsourcing vision to achieve current and future business objectives and ensure that external team is continuously optimized in performance and deliverables

Ensures clear and timely communication related to activities to internal and external stakeholders

Drives and manages activities related to MPD portfolio of responsibility to successful completion

Escalates issues/problems to oversight team or MPD portfolio cross-functional lead, as appropriate

Responsible for demonstrating Takeda leadership behaviors

Stays current with regulations / guidances on drug/device registration and life-cycle management to maximize the positive outcomes of the regulatory applications and maintain registration compliance

In coordination with regulatory leads, provides strategic guidance / advice on regulatory trends, regulations, and changes, with emphasis on those related to assigned program enabling proactive approach and planning to future business needs

Develops effective working relationships with regulatory team, cross-functional teams; company\\xe2\\x80\\x99s consultants and business partners

Mentors other Takeda team members, if required, to support scope of project work

CORE ELEMENTS RELATED TO THIS ROLE

Excellent communication, organizational, and team collaboration skills

Must work effectively with global associates and local operating companies, demonstrating strong interpersonal skills combined with cultural sensitivity

Ability to interact effectively between customers and suppliers, and to manage and resolve issues, and to provide effective feedback

Must be able to handle multiple projects simultaneously while maintaining high quality results

DIMENSIONS AND ASPECTS

Technical / Functional (Line) Expertise

Knowledge of business and regulatory environment, and ability to identify and proactively manage the interactions necessary for achieving the business goals and objectives

Awareness of global health authorities, regulations, product approvals, lifecycle processes for global markets, pharmaceuticals/devices, and regulatory affairs requirements and processes

Excellent analytical, technical, and strategic problem-solving skills

Project management abilities

Leadership

Compatible working across functions, regions, and cultures

Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing

Proven skills as an effective team leader who can engender credibility and confidence within and outside the company

Ability to distill complex issues and ideas down to simple comprehensible terms

Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization

Influence others at all levels and works collaboratively across different Global functions and Business Units (BU)

Strong ability to recognize and consider interdependencies of requirements and changing needs of a fast paced and dynamically complex business, translate solutions, communicate the risks, mitigation plans, and issues resolutions to a senior level and program team members

Works collaboratively in a cross-functional team environment, across multiple time zones

Decision-making and Autonomy

Ability to strategize, communicate and resolve issues independently

Self-motivated, self-starter with the ability to work independently and in a team with a flexible mindset

Independently manage product workload and coordinates with stakeholders to ensure timely completion of product work deliverables

Forward thinker with the ability to recommend, influence and implement organizational change and continuous innovation

Take initiative and coordinate resources to drive tasks to deadlines

Demonstrate technical and solutioning skills, influence decision making to feasible solutions

Use collaboration skills and partnerships to work within the agreed Governance model

Interaction

Efficiently/actively manage conflict in a tactful, diplomatic way, seeking effective solution for all parties

Effectively manage complex topics and a matrixed environment, building strong relationships with stakeholders enterprise-wide

Confidently engage with external vendors and manage internal stakeholders, representing the needs of the BU

Express oneself clearly and concisely at all levels, in both verbal and written communication

Demonstrate maturity of thinking

Embrace diversity, adapt to other personalities in a respectful manner that is conducive to goal achievement

Create and deliver clear and professional presentations with appropriate messaging and focused recommendations

Innovation

Comfortable challenging the status quo and bringing forward innovative solutions

Ability to take risks implementing innovative solutions, accelerating timelines throughout processes

Apply most current expedited regulatory pathways and leverage work-sharing among regulatory agencies utilizing a tailored approach

Complexity

Ability to work in a global ecosystem (internal and external) with a high degree of complexity

Understand complex issues and to propose timely, cost-effective, and achievable solutions, whilst being mindful of flexibility rather than a \\xe2\\x80\\x9cone size fits all\\xe2\\x80\\x9d approach

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

Bachelor\\xe2\\x80\\x99s degree (or equivalent) required. Masters preferred

Considerable experience within the pharmaceutical industry, including 6+ years of direct experience in regulatory affairs

Systems knowledge \\xe2\\x80\\x93 knowledge of Quality Management Systems, including RIM and EDMS

Regulatory Familiarity \\xe2\\x80\\x93 awareness and interpretation of European, US, and international regulations, including interaction with Health Authorities

Industry Knowledge \\xe2\\x80\\x93 understanding of the pharmaceutical industry and pharmaceutical companies\\xe2\\x80\\x99 operations, processes, and strategies including Regulatory Affairs processes

Analytical Skills \\xe2\\x80\\x93 ability to identify the critical issues or problems or opportunities using appropriate information; determines the causes and possible solutions to the problem

Communication \\xe2\\x80\\x93 ability to express oneself clearly and concisely to a variety of audiences. Ability to understand, analyze, synthesize and communicate to internal/external stakeholders

Teamwork \\xe2\\x80\\x93 Ability to work with team members in a friendly, professional manner. Motivate and empower others. Manage teams to work productively in a high-pressure environment

Knowledge Sharing \\xe2\\x80\\x93 Ability to capture knowledge within (and from outside) the organization; offer solutions, improve processes and deliverables, and models for others to use

Interpersonal Flexibility \\xe2\\x80\\x93 Ability to adapt to other personalities in a respectful manner that is conducive to goal achievement

Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability

Able to demonstrate skill(s) in regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies

Effective manager who is able to bring working teams together for common objectives

Experience managing relationships with vendors and/or contractors is also preferred

Must be strong communicator, and ability to explain complex regulatory issues, trends, and strategies to a wide range of stakeholders

ADDITIONAL INFORMATION

Willingness to travel to various meetings, including overnight trips

Requires approximately 10-30% travel

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!

Learn more at

Locations

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time\\n \\n \\n \\n \\n \\n

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