Associate Manager, Regulatory Europe (Clinical Trials) - Interim 6 months
Regulatory Affairs
Neuchatel, Switzerland
PREREQUISITES
Working experience in Clinical Trials in Europe
At least 1 year experience in development in Pharmaceutical Industry
Ideally: good working knowledge of European Clinical Trial Applications and procedures
Valid Swiss working permission or EU Citizenship required
Responsibilities include, but are not limited to:
Manage directly clinical trial applications (CTAs) to applicable European Health Authorities in conjunction with Celgene affiliates and support CTAs in conjunction with CROs in other relevant countries :
Plan, prepare, co-ordinate & submit CTAs including:
Communication with Regulatory Responsible Person, Affiliates, Study Team members &, CROs to gather input and collect appropriate documentation/information
Initiate response preparation to Health Authorities questions in conjunction with Regulatory Responsible and study team, where applicable
Maintain the CTA during it’s life cycle (i.e. amendments, end of trial declaration & Final Study Reports)
Participate in Study Team meetings to provide the team with procedural regulatory advice and input
Keep a breast of new developments in European legislation and guidelines applicable to clinical trials
Create and/or maintain a CTA knowledge base with up to date information on ongoing and passed trials (countries benchmarking, list of questions, submissions requirements, etc…). Share this knowledge with the relevant parties
Ensure consistent approach across all projects through close interaction with peers as well as Regulatory Responsibles and Managers
Track CTA activities including timelines and milestones. Communicate the CTA submissions and approvals to the relevant parties
QC the CTA package and oversees dispatch together with Submission Specialist
General
Assist and support Regulatory team on any other activities related to the above
Other duties related to the above within Celgene as a whole, as assigned
Core Competencies
Technical Competence: knowledge of EU Clinical Trial Directive and respective guidance documents as well as ICH guidelines
Teamwork: work effectively to share responsibility as a team member in a cross-functional team, matrix-based environment. Openness to learn from more experienced staff and to share own experience
Planning, Coordination and Organisation: excellent project planning skills; pay attention to details and demonstrate commitment to deliver high quality work to agreed timelines
Communication and Negotiation Skills: able to communicate proactively and effectively in a multi-cultural, multi-functional environment. Able to interact effectively with individuals or groups who may have different interests or goals to achieve team objective
Qualifications & Knowledge Required
Working experience in Clinical Trials in Europe
At least 1 year experience in development in Pharmaceutical Industry
Experience in European Regulatory Affairs, especially with clinical trial applications and procedures a definite advantage
Skills Required
Excellent project planning, administrative and organizational skills; attention to detail and timelines
Ability to prioritize tasks, to work on multiple tasks in parallel and under time pressure
Flexible and adaptable to changing project priorities and work assignments
Good oral and written communication skills
Fluency in written and spoken English, knowledge of other languages an advantage
Good computer skills to include: MS Word, Excel and PowerPoint
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