Global Head of Clinical Trial Regulatory Management Global Head of Clinical Trial Regulatory  …

F. Hoffmann-La Roche
in Basel, Basel-Stadt, Switzerland
Permanent, Full time
Be the first to apply
F. Hoffmann-La Roche
in Basel, Basel-Stadt, Switzerland
Permanent, Full time
Be the first to apply
Global Head of Clinical Trial Regulatory Management

At Roche, we believe it's urgent to deliver medical solutions right now - even as we develop innovations for the future. We are passionate about transforming patients' lives and we are fearless in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

The Position
The Global Head of Clinical Trial Regulatory Management (CTRM) provides strategic leadership and direction to the CTRM group globally. He/She coordinates group activities and ensures company processes are adhered to and relevant regulatory guidelines & timelines are considered / implemented into the Roche standard process/systems as applicable. You will have the opportunity to lead transformation in the regulatory space as well as:
  • Oversee the management of regulatory submissions for clinical trials.
  • Drive the identification, planning and implementation of the appropriate infrastructure for the global CTRM function in terms of organizational design, skills and roles, technology requirements, and sourcing of work
  • Lead, inspire and develop an organization of experts through mentoring, motivating and challenging. You build and support high impact working teams acting in a flexible manner while encouraging a culture of inclusiveness, authenticity and smart risk taking
  • Play a meaningful role in hiring and on-boarding key positions across CTRM as well as across Regulatory Operations

Who You Are
You're someone who wants to influence your own development. You're looking to be part of a dynamic and growing organization where you have the opportunity to pursue your interests across functions and geographies. You bring an advanced degree in Life Sciences combined with proven experience (average of 10 or more years) in drug development and/or regulatory affairs in more than one global region. In addition, you bring:
  • Average of 5 or more years' previous people management experience and managing across different global sites
  • Extensive knowledge of international regulations, processes and issues in drug/biologics development
  • Outstanding leadership of multiple projects, initiatives and teams
  • Strategic agility: broad experience in the pharmaceutical/biotechnology or related industry and able to bring this to bear in accomplishing strategic goals and objectives
  • Strong data focus/capabilities; fostering a data-driven mindset and encouraging change, innovation, and accountability within the team and function
  • Outstanding interpersonal skills: proven track record of building strong and sustainable relationships with internal and external partners and stakeholders
  • Outstanding judgment and decision-making skills

If you are proud of contributing and feel you have the dedication to teamwork and innovation that we are seeking, then Roche is the organization for you. Every role at Roche plays a part in making a difference to patients' lives. If you want to work in a passionate team, make your mark & improve lives, apply now.

Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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  • Wer wir sind At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

    Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.