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Job Details

Global Regulatory Director - Personalized Healthcare

Company: Roche
Location: Welwyn
Reference: 201811-127390
Closing Date: 10 Jan 19
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Roche are at the forefront of developing ground-breaking new medicines and consistently push the boundaries of conventional thinking and embrace innovation across our business. With a strong pipeline, we are looking for highly motivated people to support global teams to develop and gain approvals for medicines globally.We are offering a unique opportunity to join our Pharma Development Regulatory Digital Team. ...

Requirements:

Roche are at the forefront of developing ground-breaking new medicines and consistently push the boundaries of conventional thinking and embrace innovation across our business. With a strong pipeline, we are looking for highly motivated people to support global teams to develop and gain approvals for medicines globally.

We are offering a unique opportunity to join our Pharma Development Regulatory Digital Team. The Global Regulatory Director Personalized Healthcare (PHC) is a global individual contributor role providing regulatory leadership for PHC digital medicine projects in Neurosciences (Multiple Sclerosis primarily) in order to support and drive all of their regulatory aspects.

In this role you are pivotal at embedding PHC 2.0 knowledge within Pharma Development Regulatory (PDR). You stay abreast of global developments and trends in healthcare, technology / diagnostics and competition relevant to the work of Pharma Development and PDR to maintain a fully current view and perspective of internal/external influences and/or implications for assigned areas and projects.

You establish global regulatory strategies related to PHC. You analyze data, the regulatory environment and business objectives to recommend priorities. You play a key role in assuring business objectives are understood and taken into account during regulatory strategy development. You identify and align cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment. You work with other functions and functional management to ensure the relevant regulatory team has appropriate budget and resources to meet objectives and ensure compliance with agreed parameters.

You guide, coordinate and provide a first-line of internal reviews for regulatory submissions and other pertinent regulatory documentation.

You serve as the principal interface with primary reviewers from health authorities / Notified Bodies and for other interactions with relevant regulatory-related external parties; you identify the strategies for and execution of these interactions.

What else are we offering? We are dedicated to support our staff in development of their knowledge and skills and offer further career opportunities locally and globally where people demonstrate talent and aptitude.

Who are we looking for?

We are seeking a committed individual who brings:

  • Deep understanding of international regulations, processes and issues in drug/biologics/device development. Includes in-depth knowledge of GxP, GCP, ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA, Medical Device Regulation, NICE and other guidelines.
  • Experience participating in global product development teams as a regulatory contributor for global original IND/NDA/MAA filings in the US or Europe is preferred. International (2 or more markets) regulatory experience is of advantage
  • Confirmed ability to work with HAs / NBs, prior experience in medical device as well as clinical development are of advantage
  • Demonstrated ability to function in a matrixed and de-centralized environment across many key internal stakeholder groups
  • Ability to work with All PD Functions / PDR / Pharma Technical Regulatory / Roche Diagnostics to ensure alignment with the broader Roche PHC strategy and processes including compliance requirements and alignment with Roche SOPs
  • Good interpersonal, decision-making, negotiation, verbal communication and influencing skills: you have shown experience as an inspirational individual, able to build and maintain relationships with key partners both internally and externally
  • Bachelor's Degree (life sciences disciplines strongly preferred), advanced Degree in related field is preferred. 7 or more years' relevant experience in regulatory affairs or related functions in drug/biologics development/device/manufacturing
  • Ability to travel (


Ready to apply?

Roche is an equal opportunity employer.
Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs

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Contact Information:

Address:  UK Head Office
P.O. Box 8, Welwyn Garden City, Hertfordshire, United Kingdom
AL7 3AY
England
Tel:  +44 1707 36 6000
Fax:  +44 1707 33 8297
Website:  Visit Our Web Site

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