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Regional Regulatory Therapeutic Head - Switzerland

We have an exceptional opportunity to join a leading pharmaceutical company in a key management position within the Drug Regulatory Affairs structure. We are looking to recruit from across the European and International markets a highly capable and proven leader from the regulatory development environment. This person will have led and contributed to the development of major pharmaceutical products/programmes and will have built an extensive background in managing and leading a regulatory function.

The opportunity to join a company in a significant management role of this profile makes this proposition all the more attractive and we therefore expect the strongest of skill-sets to occupy the role. The client we represent has asked us to conduct an extensive search programme to ensure that they are acquiring a professional that brings leadership, strategic and tactical awareness and a solid scientific regulatory background. This robust capability will be accompanied by excellent skills in areas like communication, planning, resource organisation, presentation and negotiation.

We invite enquiries from all candidates that might wish to apply for the role or who would like an informal discussion about the full dimensions of this position, including the job responsibilities, experience requirements and organisational structure.

Job Purpose:

The European Regulatory Therapy Head leads and optimizes strategically the DRA regulatory support of development projects/major line extensions through development, registration and approval including post approval commitments for a specific Business Franchise or Business Unit in this region.

          Major Accountabilities:

• Supervises DRA Managers including performance management for EU Regulatory Managers.  
• Drive Development of high quality European regulatory strategy through support of the different local business franchise/unit Managers.
• Contribute senior level operational and strategic regulatory input into business franchise and leadership as required, either directly or through the global DRA head.
• Oversee day-to-day operations for region and ensure adequate staffing of EU projects. Ensure adherence to internal policies and processes.
• Contribute to strategic portfolio management in collaboration with US DRA Therapy Head and Global DRA Therapy Head.
• Ensure high quality and professional interactions with health authorities in Europe including participation in key formal and informal HA contacts
• Ensure European HA interactions and registration activities are in line with global strategy
• Take on project responsibilities as Global Project Team Representative for 1-2 projects as needed
• Commitment to develop people, process, innovation and external focus.
• Representation of DRA within specific internal and external meetings.
• Representation of DRA franchise at EU DRA Management Team meeting

          Key Performance Indicators:

•        Timely preparation of high quality regulatory documents, IMPDs, PIPs, CTAs and dossiers

•        Main European Health Authority issues are highlighted in Regulatory Functional Plans

•        EU Health Authority interactions at appropriate time points during development with good negotiation skills

•        Regulatory functional excellence of DRA Managers to ensure earliest registrations with optimal labelling

          Job Dimensions:  

          Number of associates: May be 5 – 10 direct reports (recruitment ongoing)

          Financial responsibility:        (Budget, Cost, Sales, etc.)

          Responsible for the training & travel budget of their section.

          Impact on the organisation:

Strategic influence on the development portfolio. Obtaining approvals and securing adherence of the company to regulatory requirements. Ability to attract talent, manage performance and retain talent to achieve high performing organization. Company seen as a credible, ethical and preferred partner. Global internal consistency.

Ideal Background: 

Education (minimum/desirable):           

          MD and/or PhD in Life Sciences, Pharmacy or Medicine    

          Languages:                     

          Fluency in English (oral and written)         

          Experience:           

• Considerable experience in the pharmaceutical industry and sufficient relevant regulatory experience including experience in the following:
• Project lead on a top priority project
• Involvement in an MAA submission and approval.
• Taking a leading role in Health Authority negotiations (national /CHMP)
• Leading role in a DRA specific or cross functional ad hoc special project.
• Due diligence activities for licensing activities as required.
• Significant team management experience with cross functional and international responsibilities.
• Proven success in global drug regulatory submission and commercialization.
• Proven ability to analyze and interpret efficacy and safety data.
• Demonstrated ability to manage and develop DRA therapy franchise
• Track record in managing and developing people.

Please contact Liftstream on +44 (0)207 370 6451 or info@liftstream.com  quoting reference F4823.

This position is now closed - September 28th 2008