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(Senior) Regulatory Affairs Specialist (m/f/d)

ISG Personalmanagement GmbH published 20 days ago
  • Wien
  • Full Time

Your Responsibilities

  • Overall responsibility for the local Regulatory Affairs area in Austria
  • Ensuring compliance with local and global regulatory requirements for pharmaceutical and non-pharmaceutical products
  • Managing regulatory activities for the local portfolio
  • Planning and preparing submissions for marketing authorization and variation applications, indication extensions, line extensions, and renewals
  • Primary contact person for local health authorities
  • Close collaboration with Global Regulatory Affairs as well as local and cross-functional teams
  • Ensuring timely and high-quality processing of authority requests and regulatory documentation
  • Reviewing and approving artwork, mock-ups, and promotional materials in accordance with applicable regulations
  • Maintaining relevant regulatory systems, databases, and SOPs, including RIMS

Your Profile

  • Degree in a scientific discipline (Chemistry, Biology, Biotechnology, Pharmacy, Veterinary Medicine, Medicine) is an essential requirement
  • At least 5 years of experience in Regulatory Affairs for medicinal products, food supplements, and medical devices
  • Experience with regulatory and quality systems (e.g., RIMS, Artwork Management, TrackWise Digital)
  • Excellent communication skills in German and English
  • Very good knowledge of MS Office 365
  • Strong communication, interpersonal, and presentation skills
  • Analytical, structured, and independent work approach
  • Innovative mindset and critical thinking abilities

Angelini Pharma is an equal opportunity employer.
We believe that diversity is a great value that contributes to individual and corporate success. We are committed to creating a diverse and inclusive environment.

In addition to a respectful environment, we offer attractive working conditions in a modernly managed company that promotes independent and flexible working styles for its employees. For this position, we offer a minimum gross monthly salary of EUR 3,560.00 (collective agreement for the trade sector 2026, F/3 with at least 7 years of relevant experience) with a willingness to pay above the market rate depending on qualifications and experience.

Interested?


We look forward to receiving your meaningful application to our consultant under reference number 112.039, preferably via the ISG career portal or by email.

Also visit isg.com/jobs – here you will find new job offers every day.

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