Regulatory Affairs Specialist, Pharma Services EMEA

hace 4 semanas

Granollers, España Brenntag A tiempo completo

Our team in Granollers currently has an opening for a Regulatory Affairs Specialist, Pharma Services EMEA

YOUR ROLE & RESPONSIBILITIES

PersonalProfile Essential Criteria: University degree in life sciences General knowledge of pharmaceutical industry requirements and regulations on APIs, Excipients and raw materials. Knowledge of European National Competent Authority requirements for distribution of APIs, Excipients and raw materials to the pharmaceutical industry. Fluent in Spain & English (speaking and written) & Italian (speaking) Team player, strong communication and interpersonal skills, with ability to work across all levels, and functions

Maintasks: Cover Spain, Portugal and Italy to provide support the South regional Pharma Sales Team on topics around the supply of raw materials into the pharmaceutical industry including regulatory, legal, compliance, quality and product safety. Completion of technical and regulatory documentation and information requests from customers for supply of raw materials into the pharmaceutical industry (questionnaires, supply chain agreements, QAA’s & TA’s) in and English. Contribute as part of team to maintenance of EMEA document management system to keep product and supplier information up to date. Request product and supplier information directly from manufacturers and indirectly via other internal channels.
Process Change Control Notifications. Maintain customer specific information such as completed questionnaires, supply chain agreements, QAA’s, TA’s in the designated database. Creation and ongoing update of product regulatory information in standardized information packs.  Support of customer, regulatory and 3rd party audits. Reporting and documenting customer requests via KPIs.

YOUR PROFILE

2 years previous experience working with regulatory documentation. Knowledge of ISO9001, food safety or GxP systems. Proficient in German (speaking and written).

OUR OFFER

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