Regulatory Career Connections: Quality/Risk Management jobs ...

Dassault Syst?mes, the 3D Experience Company, provides business and people with virtual universes to imagine sustainable innovations. Its world-leading solutions transform the way products are designed, produced, and supported. Dassault Syst?mes? collaborative solutions foster social innovation, expanding possibilities for the virtual world to improve the real world. The group brings value to over 150,000 customers of all sizes, in all industries, in more than 80 countries. For more information, visit www.3ds.com. CATIA, SolidWorks, ENOVIA, SIMULIA, DELMIA, 3D VIA, 3DSwYm, EXALEAD and Netvibes are registered trademarks of Dassault Syst?mes or its subsidiaries in the US and/or other countries.

To strength and accelerate our Life Sciences Industry expansion, Dassault Syst?mes (3DS) is looking for a Business Consultant Director H/F experienced in Pharmaceutical Regulatory Affairs.

You are the Life Sciences Regulatory Affairs reference for our customers as well as internally at 3DS. You contribute actively to the 3DS Life Sciences worldwide strategy.

You are the inspirer of the VP Industry leader to position and promote our Life Sciences Experience Platform for Regulatory Affairs. Interacting with our customers, you also represent 3DS in key Regulatory Affairs events and associations.

You have a deep experience of the Life Sciences Industry and its regulatory processes, gained at a National/International Regulatory Agency (FDA, EMA, ANSM?) or in a pharmaceutical company, as Regulatory Affairs expert.

Following a minimum 5 years experience where you directly participated to a global drug submission, you are familiar with industry lifecycle (IND, IMPD, NDA, CP, DCP, MRP, NP, PSURs) and associated business processes like product variations and packaging.

Interactions with regulatory bodies are your day to day activities. You have detailed knowledge of EU/US/JP regulations and guidelines on drug development and submissions both pre and post approval. You are familiar with on-going process digitalization (eCTD, electronic transmission?). Your knowledge in related domains like Pharmacovigilance, Medical Device processes or GxP is a plus. Your core skills in Pharmaceutical segment allow you to well understand the focus and the challenges of our clients. Dassault Syst?mes offers you the power of its collaborative innovation platform allowing global teams collaboration through the enterprise ecosystem, directly supporting the ongoing pharmaceutical market (r)evolution. Guiding our platform evolution to match strategic pharmaceutical Regulatory Affairs current and future expectations will be your target.

Source: http://regulatorycareers.raps.org/jobs/4893288/business-consultant-director-lifesciences-specialized-in-regulatory-affairs-h-f

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