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

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

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.

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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.

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