EMEA Regulatory Affairs Senior Associate
That's XPE. For one of our clients we are looking for: EMEA Regulatory Affairs Senior Associate Organisation description:
XPE Pharma & Science is looking for 3 EMEA Regulatory Affairs Senior Associates, for one of our clients. The mission is of 6 months, with possibility of extension. This person will have to obtain and maintain marketing authorization for product(s) in Middle-East/ Africa region. A minimum of 4 years of experience are required; regulatory or equivalent experience within a pharma company CRO, or similar organization are preferred.Job description:
Under limited supervision responsible for: Obtain and maintain marketing authorizations for products in Middle-East/Africa region. Essential duties and responsibilities Compile and submit in a timely manner regulatory documents according to regulatory requirements; Respond to regulatory authorities with strict deadlines; Maintain regulatory files in a format consistent with requirements; Maintain and update existing regulatory authorizations; Represent or lead Regulatory Affairs in small project teams.Profile:
Education Bachelor's degree or country equivalent in pharmacy ore related scientific discipline. Higher degree/PhD would be an advantage. Experience A minimum of 4 years of experience Regulatory or equivalent experience within a pharmaceutical company CRO, or similar organization. Functional/Specific competences Compile with regulations and standards and protect the company's public reputation; Scientific knowledge; Written and verbal communication skills; Negotiation skills; Technical systems skills (e.g. word processing, spreadsheets, databases, online research); Manage multiple projects and deadlines; Ability to contribute to multiple projects from a regulatory affairs perspective. Skills Excellent spoken and written English is required. Computer skills.Offer:
Highly professional working environment; Open end contract on XPE payroll.
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002 XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713