Imp asphalion

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EUROPEAN PHARMACEUTICAL STUDENTS’ ASSOCIATION

IMP TRAINING PLACEMENT OFFER PARTNER Name

Asphalion

Description

Asphalion is an International Drug Development and Regulatory Affairs Consultancy based in Barcelona. The firm is structured into working groups for International Registration Procedures, Clinical and Medical Writing, Electronic Submission of Regulatory Data, CMC/Quality and Pharmacovigilance.

Web

www.asphalion.com

PLACEMENT Area

Regulatory Affairs

Name

Regulatory Affairs Officer

Description

• Preparation, elaboration, and revision of registration dossiers; presentation of those to Health Agencies and/or Organisms and management of all related documents. • Preparation of regulatory strategy dossiers or reports. • Evaluation and revision of non-clinical and quality documentation; participation in drug development programs, in collaboration with R&D and CRO groups. • Communication with international agents for regulatory support.

Location

Barcelona, Spain

Duration

6 months (flexible start)

Salary

Salary according to experience and added value

• University degree in Pharmacy, Chemistry, Biology or Medicine. Mandatory Qualifications • Fluent in English required. Knowledge of Spanish or other languages highly valued. • Experience will be valued with same functions in the registration field of human or veterinary medicines, APIs, medical devices or similar will be valued.

Reception

Logistics* handled by the National IMP Coordinator *Accommodation, VISA arrangements, Health Insurance, etc.

APPLICATION Deadline

15th of October 2013

More Info

• vp.mobility@epsa-online.org | Vice-President of Mobility | Rita Figueira • central.imp@epsa-online.org | Central IMP Coordinator | Sonia Colianni


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