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Regulatory Affairs Strategy Lead - Rare Diseases (EUCAN - Europe & Canada)

Apply Now Email Me Job ID SR0038550 Date posted 10/10/2019 Location: Zug, Switzerland

Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda.

Join us as a Regulatory Affairs Strategy Lead – Rare Diseases (EUCAN - Europe & Canada) in our office in Zürich, Switzerland.

OVERVIEW

The Regulatory Affairs Strategy Lead – Rare Diseases defines, develops and leads regional strategies to maximize regulatory and patient access success to enable patient access to meaningful medicines in alignment with program objectives.

He/she effectively communicates objective assessments of the likelihood of success of these regulatory strategies. Provides strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs and/or oversight of marketed product support, while maintaining full compliance with applicable regulatory requirements.

He/she provides regulatory expertise for multiple projects including one highly complex project within core therapeutic area, focused on non-clinical and clinical aspects of drug development and / or post-marketing compliance and life cycle management.

He/she mentors team members, if required, to support scope of project work.

He/she may be called upon to act as deputy to the Regional therapeutic area lead and/ or Region regulatory head, attending internal leadership team meetings, as appropriate

He/she monitors and informs on emerging trends, regulations and changes, with emphasis on those related to therapeutic areas and/ or region of responsibility enabling proactive approach and planning to future business requirements. May be called upon to provide direction to senior leadership, as relevant.

For Europe based roles, manages and oversees interactions with EMA and national health authorities (and HTAs jointly with value and access team in context of parallel consultation) in the Europe Union and European Economic Area for all products in defined therapy area.

Key Accountabilities include, but are not limited to:

  • Ensure global/regional regulatory strategies are written, reviewed and executed according to plan and appropriately capture patient access requirements.  Usually has own Regulatory lead role. Provide strategic and tactical advice and guidance to allow the timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements.
  • Partner with the regional/LOC market access and LOC RA colleagues to define the strategy for, and to lead and oversee joint interactions with regional and national regulatory/health agency/HTA bodies on value and evidence topics and to support heath authority decision making.
  • Collaborates with Takeda counterparts and IBT to ensure a regional regulatory strategy is created and executed upon for all projects within area of responsibility. Identifies regulatory requirements and trends across scope of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas.
  • Directs and oversees multiple projects, generally has regional oversight for compounds in a minimum of one disease area.
  • 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 importance of regulatory documents for value and access discussions and partners with access functions to support access applications.
  • In collaboration with global colleagues, works to resolve regional critical conflicts in global regulatory strategies and oversee critical deliverables outside of region as agreed within the global regulatory strategy.  Approves regional regulatory strategies and authors for more complex regulatory strategies as needed; oversee execution, generally delegates to staff and / or vendor.
  • Leads and manages meetings and / or interactions with regulatory authorities and agency meetings; negotiates on behalf of project team as necessary.
  • Lead regulatory reviewer in due diligence for licensing opportunities.
  • Proactively builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc.) contacts/influence to achieve Takeda strategic goals and objectives.
  • Identifies regulatory requirements and trends across therapeutic area(s) of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas.
  • Ensures coverage for project and therapy area(s) responsibilities; Elevates needs when necessary
  • Presents to senior management.

Education & Experience Requirements:

  • BSc. Advanced scientific related degree preferred; BA accepted based on experience.  Advanced degree preferred
  • Extensive pharmaceutical industry experience.  This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience in both development and post-marketing phases. 
  • Solid working knowledge of regulations and guidance governing drugs and biologics in all phases of development, including post-marketing, in the US and/or EU (relevant to role), with a good understanding of basic regulatory requirements in emerging markets. Understanding of evidence requirements beyond the regulators (e.g. HTA bodies)
  • Understands and interprets complex scientific issues across projects and therapy area(s) of responsibility as it relates to regulatory requirements and strategy.
  • Preferred experience in managing multiple filings; or managing multiple programs in closely related development area; expertise in either EU or US region (as relevant to role) with global involvement also preferred.
  • Generally strong in all basic skills sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
  • Must be strong overall and able to train/develop staff 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, within global teams and communicating with senior leadership.
  • Must be strong leader that creates vision for group.  Inspires and motivates group.  Takes stand on important issues in productive, respectful way. Able to mentor and develop skills of staff.
  • Experience in managing personnel required; experience managing relationships with CROs and/or contractors also preferred.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Discover more at takedajobs.com.

What Takeda Can Offer You

To further support and inspire our employees, our benefits include: Competitive basic salary, Annual Bonus, Car Allowance, Long Term Incentive Plan, Contributory Pension Scheme, Private Health Cover and Life Assurance.

Empowering Our People to Shine

Learn more at takedajobs.com

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

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