Consultant - Global DRA

Basel-Country  ‐ Onsite
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Description

Our client is currently looking for a Global DRA Project Leader, for a 12 month project in the Basel area. Please find below some of the requirements.

REQUIRED QUALIFICATIONS AND EXPERIENCE
  • Bachelor's Degree in life sciences, secondary degree (PhD) preferred
  • At least 5 years of regulatory experience
  • Good knowledge of regulatory legislation and guidelines (ICH and EU) and major global regulatory systems
  • In depth knowledge and experience with EMA and NCA in EU. Experience with various types of EU submissions
  • Good understanding of the regulatory aspects at various stages of development, from entry-intoman to post approval activities
  • Experience working and communicating with the EMA/NCA, including coordinating and managing meetings for scientific advice
  • Familiarity with clinical trial methodology and statistics
  • Excellent communication, interpersonal, negotiation and problem solving skills
  • Organizational awareness (e.g. understands interrelationships between functions, departments and business priorities)
  • Effective team player, with experience working in cross-functional and global teams, but also able to work independently
  • Ability to work within tight timelines with excellent project management skills
  • Accuracy, reliability and diligence
  • Excellent spoken and written English


RESPONSIBILITIES AND TASKS

The Drug Regulatory Affairs (DRA) Project Leader role is dependent on the geographic region in

which the leader is employed. For assigned projects the role may be the global leader or partner role.

EU DRA Project Leader Role
  • Provide EU regulatory strategic input, including interpretation of guidelines relevant to the development and maintenance of assigned project(s) to Global Project DRA Leader, clinical eam, Technical operations and/or LCT
  • Liaise with EMA as primary regulatory contact and with other EU NCA in collaboration with affiliates and partners for assigned projects including planning, coordination, preparation and execution of meetings and teleconferences
  • Ensure appropriate communication of correspondence from EMA/EU NCA to colleagues, teams and management in accordance with agreed communication routes.
  • Ensure EU labelling (Annexes and associated documents) remains in compliance with CCDS and EU/ICH regulations
  • Responsible for and contributes to ensuring creation, critical review, finalization of EU specific regulatory documents; i.e. IMPD, CHMP Scientific Advice- and other meeting briefing books, annual reports, Orphan drug applications, PIP, Module 1 documents for EU MAA etc.
  • Remain current on Regulatory Intelligence, new guidance documents and the like in order to provide fully informed participation in development programs
  • Contribute the EU regulatory perspective as required on due diligence activities in support of potential new business opportunities


If you are interested please find my contact details below.

Sebastian Spaniol
s.spaniol'@'realstaffing.com
Start date
01/2016
Duration
12 months
From
Real Staffing
Published at
11.01.2016
Project ID:
1048822
Contract type
Freelance
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