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| Manager, Global Regulatory Oncology |
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Assist in preparation of global regulatory strategies
Manage the submission and approval of applications for clinical trials (WW) and marketing applications, full submissions and variations in 3 ICH regions
Major Responsibilities:
Represent GRA in Global Project Teams
Lead GRA sub-team
Manage the regulatory submission process through to approval including management and coordination of the preparation of all regulatory documentation
Manage the regulatory agency interactions, document preparation, co-ordination rehearsals and minutes (may be under supervision of a TA Head or delegate)
Prepare regulatory strategies for projects (may be under supervision)
Review of protocols, reports and all types of regulatory documentation (quality, safety, efficacy, and labeling) including CTAs |
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Bachelors Degree (Life Science)
MBA
Doctorate
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7 years + |
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English : Speak / Write Fluently
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open-ended |
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unspecified |
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B permit |
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Geneva |
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Degree in a Life Science or related discipline, higher degree preferable (PhD, MSc, MBA)
Excellent spoken and written English
Minimum of 7 years’ industry experience of which at least 5 years’ regulatory experience
Experience in preparation and submission of a full submission/or large variation/supplement in at least one ICH region through to authorization
Experience with regulatory agency interactions and preparation of documentation to support interactions
Experience in CTA requirements WW
Knowledge of special consideration opportunities WW
Knowledge of international regulatory affairs (demonstrated by above)
Experience in preparation of Regulatory strategies under supervision
Experience with maintenance of regulatory authorizations in at least one region
Experience with supporting a project with development activities in at least two regions
May have eCTD experience |
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Merck Serono is the division for innovative small molecules and biopharmaceuticals of Merck KGaA.
Merck Serono’s global headquarters are located in Geneva, Switzerland. |
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