Product Compliance Bio Pharma Specialist and Local Regulatory Affairs Officer (m/f/d)

      VWR International GmbH

      Vienna - vor 2 Wochen

      GIVE YOUR CAREER A NEW SWING AND DISCOVER
      THE PROFESSIONAL POSSIBILITIES WITHIN AVANTOR

      Product Compliance Bio Pharma Specialist and Local Regulatory Affairs Officer (m/f/d)

      R-112045
      Job Location : Vienna

      Your Responsibilities

      The Bio Pharma Specialist :

      • Is centrally responsible for legal tracking, vigilance, regulatory guidance and regulation interpretations that impact the business
      • Keeps informed of regulatory regulations & changes
      • In cooperation with other stakeholders implementation of the necessary changes to maintain company compliance, including registrations when required
      • Give input and work together with Product Management and OEM to secure compliant products are placed on the market
      • Provide professional support on expert subject to customers and internal stakeholders on request, including QA / Regulatory agreements to protect our business and to ensure that compliance/customer requirements are established properly
      • Performs Regulatory Product Compliance Bio Pharma internal audits when required

      The Local Regulatory Affairs :

      • Is the local contact with authorities (participating on inspections, declarations & reporting, licenses requests)
      • Investigate queries with local authorities
      • Local Legal requirements / Legislation follow-up and update of Central team
      • Provide inputs for suppliers product range introduction if local legislation to consider
      • Support for central projects with local implementations
      • Ensure that local organisation is compliant with the Legal requirements / Legislation
      • Suspect customers / transactions to raise to Central team & authorities
      • Provides Regulatory support to the local Business and Operations Teams
      • Check and approve license/EUD sent by customer and coordinates with Central REGA for unblockings
      • Authority to block deliveries
      • Communicate and up-date Central REGA on all local activities (inspections, up-date in legislation, license requirements)

      Your Profile

      • Science education or equivalent in Bio Pharma or Bio Chemistry
      • Proven experience in Bio Pharma
      • Experience in Lab Supply or equivalent experience required at a minimum
      • Need an awareness of regulations / legislations
      • Ideally experience in Product Compliance regulations and interpretation, such as FDA regulations, Local Legislation, IPEC Guidelines, Drug Quality, cGMP,GDP, GLP, GDocP and applicable Pharmacopeias.
      • Excellent Analytical skills
      • Strong interpersonal skills
      • Good communication and planning skills
      • Extended computer skills, SAP would be an advantage
      • Fluent in German and English

      Our Offer

      If you are looking to put your energy in growing in this role as a next step, we are certainly welcoming your application.

      We are required by Austrian law to post a minimum salary. The minimum yearly gross salary for this position is EUR 47.600. Depending on experience and qualification we are willing to overpay.

      Apply online

      Contact person
      Dominik Kalthof, Talent Acquisition Partner

      Avantor(R) is a leading global provider of integrated, tailored solutions for the life sciences and advanced technology industries. Strengthened by the recent acquisition of VWR, the Company is a trusted partner to customers and suppliers from discovery to delivery. With operations in more than 30 countries and a diverse portfolio that includes more than four million products, Avantor enables customer success through innovation, cGMP manufacturing and comprehensive service offerings. Collectively, we set science in motion to create a better world.

      Learn more at www.avantorsciences.com