Senior Manager, EUCAN Regulatory Lead GI

Zurich, Switzerland

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Overview

Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

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What makes a successful member of our team?

We take action and make decisions by focusing on our four priorities in this order:

• 1

  Putting the patient
  at the center



• 2

  Building trust
  with society



• 3

  Reinforcing our
  reputation



• 4

  Developing the
  business

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• Our people

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• Anders Tellefsen

  Procurement Lead, Northern Europe

  “Takeda is a unique place to work as there is no ‘every-day routine’ around here – it’s very a dynamic environment where change of plans and adjustments of approach are the constants... This allows for interesting cross-function collaboration and – if you’re up for it - a high degree of influence on your daily job and workplace.”



• Yves Leurquin

  Regional Head, Europe, Vaccines

  “Takeda is a great place to work as the company invests in the continuous development of its employees offering training, coaching, mentoring and open exchanges between all levels of the organization. Also, it is fulfilling to know that, within the Vaccine Business Unit, we are developing and delivering innovative vaccines impacting the lives of millions of people around the world.”

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Opportunity

• Inclusive

  Here, you will feel welcomed, respected, and valued as a vital contributor our global team.



• Collaboration

  A strong, borderless team, we strive together towards our priorities and inspiring mission.



• Innovation

  Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.



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• People-First

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• Empowerment

  Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

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Senior Manager, EUCAN Regulatory Lead GI

Apply NowJob ID R0025945Date posted 03.02.2021Location Zurich, Switzerland

By clicking the “Apply” 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’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

OBJECTIVE:

• Provides strategic and tactical regional regulatory advice and guidance to teams to achieve timely and efficient conduct of development programs while maintaining full compliance with applicable regulatory requirements.


• Effectively communicates objective assessments of the likelihood of success of these regulatory strategies.


• Provides regulatory expertise and strategic focus for assigned development projects and /or marketed product life cycle management


• Monitors and informs on emerging trends, regulations and changes, with emphasis on those related to project areas and/ or region of responsibility enabling proactive approach and planning to future business requirements


• Primary EMA contact for project(s)/products of responsibility.


• Informs the business and manages interactions with EMA and national health authorities and HTAs (jointly with value and access team in in context of parallel consultation) in the Europe Union and European Economic Area for specific product(s).

ACCOUNTABILITIES:

• Leads the regulatory working team for own region and represents region as needed at project team and ensures regional regulatory lifecycle management strategy and submission planning written and executed according to plan – or oversees if delegated to staff and/or vendor


• Partner with the regional/LOC RA and market access colleagues to understand market access and reimbursement topics and support opportunities to drive consolidated inputs into regional product development plans.


• For the project(s)/product(s) of responsibility, collaborates with Global and Regional colleagues for the authoring of global regulatory strategies and ensures own critical deliverables as agreed within the global regulatory strategy and planning are completed.


• Where responsibility includes a marketed product, provides oversight to ensure regulatory compliance, including oversight of the product related data in the registration database. 


• Accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within region of responsibility (E.g. EMA submissions for Europe).


• Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications as needed.


• Identifies relevant regional regulatory requirements and provides regulatory guidance, and expertise to internal team on the assigned project(s) of responsibility.  Authors and reviews global and/ or regional regulatory strategies as well as executes day-to-day activities for projects.


• May include some oversight of vendor activities.


• Leads and manages meetings in own region (e.g. EMA for Europe) and have awareness of relevant regulatory agency meetings scheduled with other regions (such as FDA) or Local Takeda affiliates for project(s)/product(s) of responsibility.


• May be called upon to support in due diligence for licensing opportunities, development and /or marketed product opportunities.


• Builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) contacts/influence to support Takeda strategic goals and objectives.


• Identifies regulatory requirements across area(s) of responsibility, and provides regulatory guidance, and expertise to global development team and /or Region in these areas.


• Identifies and proposes solutions to the management of resource gaps for areas of responsibility.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• BS degree or equivalent in science; advanced degree preferred


• Experience within the pharmaceutical industry, including direct experience in regulatory affairs in development and /or post-marketing phases.


• Working knowledge of regulations and guidances governing drugs and biologics in development, including post-marketing in the US and/or EU (relevant to role).A good understanding of basic regulatory requirements in emerging markets is a plus. Awareness of evidence requirements beyond the regulators (e.g. HTA bodies)


• Understands and interprets complex scientific issues and capability to relate to regulatory requirements and strategy.


• Proven regulatory submissions capability in a region (Europe, US, EM)


• 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 the area of 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.


• Generally strong in working well with others and within global teams.


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


• Experience managing relationships with CROs and/or contractors preferred.

Locations

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time



Job ID R0025945Apply NowEmail Me

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Senior Manager, EUCAN Regulatory Lead GI

Apply NowJob ID R0025945Date posted 03.02.2021Location Zurich, Switzerland

By clicking the “Apply” 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’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

OBJECTIVE:

• Provides strategic and tactical regional regulatory advice and guidance to teams to achieve timely and efficient conduct of development programs while maintaining full compliance with applicable regulatory requirements.


• Effectively communicates objective assessments of the likelihood of success of these regulatory strategies.


• Provides regulatory expertise and strategic focus for assigned development projects and /or marketed product life cycle management


• Monitors and informs on emerging trends, regulations and changes, with emphasis on those related to project areas and/ or region of responsibility enabling proactive approach and planning to future business requirements


• Primary EMA contact for project(s)/products of responsibility.


• Informs the business and manages interactions with EMA and national health authorities and HTAs (jointly with value and access team in in context of parallel consultation) in the Europe Union and European Economic Area for specific product(s).

ACCOUNTABILITIES:

• Leads the regulatory working team for own region and represents region as needed at project team and ensures regional regulatory lifecycle management strategy and submission planning written and executed according to plan – or oversees if delegated to staff and/or vendor


• Partner with the regional/LOC RA and market access colleagues to understand market access and reimbursement topics and support opportunities to drive consolidated inputs into regional product development plans.


• For the project(s)/product(s) of responsibility, collaborates with Global and Regional colleagues for the authoring of global regulatory strategies and ensures own critical deliverables as agreed within the global regulatory strategy and planning are completed.


• Where responsibility includes a marketed product, provides oversight to ensure regulatory compliance, including oversight of the product related data in the registration database. 


• Accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within region of responsibility (E.g. EMA submissions for Europe).


• Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications as needed.


• Identifies relevant regional regulatory requirements and provides regulatory guidance, and expertise to internal team on the assigned project(s) of responsibility.  Authors and reviews global and/ or regional regulatory strategies as well as executes day-to-day activities for projects.


• May include some oversight of vendor activities.


• Leads and manages meetings in own region (e.g. EMA for Europe) and have awareness of relevant regulatory agency meetings scheduled with other regions (such as FDA) or Local Takeda affiliates for project(s)/product(s) of responsibility.


• May be called upon to support in due diligence for licensing opportunities, development and /or marketed product opportunities.


• Builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) contacts/influence to support Takeda strategic goals and objectives.


• Identifies regulatory requirements across area(s) of responsibility, and provides regulatory guidance, and expertise to global development team and /or Region in these areas.


• Identifies and proposes solutions to the management of resource gaps for areas of responsibility.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• BS degree or equivalent in science; advanced degree preferred


• Experience within the pharmaceutical industry, including direct experience in regulatory affairs in development and /or post-marketing phases.


• Working knowledge of regulations and guidances governing drugs and biologics in development, including post-marketing in the US and/or EU (relevant to role).A good understanding of basic regulatory requirements in emerging markets is a plus. Awareness of evidence requirements beyond the regulators (e.g. HTA bodies)


• Understands and interprets complex scientific issues and capability to relate to regulatory requirements and strategy.


• Proven regulatory submissions capability in a region (Europe, US, EM)


• 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 the area of 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.


• Generally strong in working well with others and within global teams.


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


• Experience managing relationships with CROs and/or contractors preferred.

Locations

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time



Job ID R0025945Apply NowEmail Me

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