12 days old

Global Regulatory Group Director for Personalized Healthcare

Roche
Basel, BS

The Global Regulatory Director Personalized Healthcare (PHC) is a global role and is providing regulatory leadership for a portfolio of PHC Projects, in order to support and drive all of its regulatory aspects.

In this role your main responsibilities and accountabilities are:

  • Oversee establishment of regulatory strategies related to PHC, in particular Digital Health
  • Stay abreast of global developments and trends in healthcare relevant to the work of Product Development (PD) and Product Development Regulatory (PDR) to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for assigned areas and projects, the regulatory environment and business objectives to recommend priorities
  • Provide regulatory expertise and leadership to site, regional or global cross-functional teams and other groups
  • Play a lead role in helping ensure effective balance of time, cost, quality and risk so that regulatory strategies meet the needs of patients, prescribers, payers, regulators and Roche
  • Play a key role in assuring business objectives are understood and taken into account during regulatory strategy development
  • Manage Digital PHC Team, including providing ongoing leadership of regulatory deliverables and guidance for a portfolio of PHC projects
  • Ensure cross-functional perspectives and expertise are incorporated into PHC regulatory plans prior to decisions being made
  • Manage decision-making and conflict resolution surrounding regulatory issues within and across cross-functional teams.  Works with team leaders or functional management to address issues that have been escalated, as necessary.
  • Responsible to ensure all PDR deliverables associated with a portfolio of PHC projects or other assignment are completed within defined timelines and meet regulatory and other company guidelines
  • Develop regulatory risk management and contingency plans; communicates plans, as appropriate

We would like you to bring:

  • Bachelors Degree required (life sciences disciplines strongly preferred), advanced Degree in related field is preferred. 15 or more yearsâ relevant experience in regulatory affairs or related functions in drug and diagnostic development;
  • Broad understanding of international regulations, processes and issues in drug/biologics/device development. 
  • Experience participating in global product development teams. Strong cross-functional teaming skills: has consistently excelled in cross-functional teams and regularly demonstrated him/herself as a leader among peers
  • Ability to work with HAs / NBs, prior experience in medical device as well as clinical development are strong plus.
  • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
  • Strong financial acumen: proven abilities for planning, development and oversight of project budgets and other resources
  • Aptitude or proven ability to guide the work of others (can lead and motivate others, as well as prioritize and oversee their work through to successful outcomes)
  • Ability to travel (<30%)
Posted: 2018-12-07 Expires: 2019-01-06

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Global Regulatory Group Director for Personalized Healthcare

Roche
Basel, BS

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