Regulatory Compliance Expert

vor 1 Woche

Kundl, Tirol, Österreich Sandoz GmbH Vollzeit

Regulatory Compliance Expert (MRC) (d/f/m), Sandoz, Kundl, Tyrol, Austria


Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.


Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates.

This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Join us as a Founder of our 'new' Sandoz

Your key responsibilities:

  • Your responsibilities include, but are not limited to:
  • Perform typical MRC tasks for the STO site, e.g. ensuring regulatory assessments for change controls are provided by molecule managers in MRC central groups in a timely manner
  • Evaluate and consolidate special country specific requirements, provision of preevaluation regulatory advice and feedback
  • Ensuring the specific STO site change requests and supporting documentation are prepared in accordance with MRC expectations and requirements in a timely manner
  • Participate and assess MRC regulatory impact in STO change review board meetings
  • Liaising with the specific STO site to prioritise changes according to business criticality, and communicating prioritisation decisions to molecule managers in MRC central groups
  • Assigning TrackWise regulatoryactions to molecule managers in MRC central groups
  • Collating and providing any additional documentation and or data requested by molecule managers in MRC or IM&S central groups to support preparation of regulatory submission packages
  • Organising notarization, apostille, and legalization of documents, as necessary
  • Communicating regulatory risks associated with implementation of a change control or other regulatory submissions, as identified by molecule managers in MRC central groups, to relevant STO site groups
  • Reviewing and or approving defined sections of submission packages prepared by MRC central groups (as per WP , to ensure alignment and compliance with STO documentation
  • Supporting and coordinating the STO site input to deficiency letter responses being managed by MRC
  • Monitoring, tracking, and communicating the dispatch, submission, and approval status of MRC submission packages related to the STO site products via regular followup's with MRC Colleagues
  • Key performance indicators
  • Ensuring change request evaluations are completed by MRC central groups within a nominal timeframe of 15 calendar days
  • Ensuring specific STO site documentation to support MRC submission packages is provided in a timely manner, for example not more than 6 months after the implementation date for an EU Type IA variation
  • Minimizing stockout situations by effective oversight of MRC activities associated with regulatory submissions and approvals
Diversity and Inclusion

  • We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
Minimum Requirements

What you'll bring to the role:

Essential:

  • Bachelor's degree in a relevant field (e.g., regulatory affairs, pharmaceutical sciences, chemistry, or related discipline).
  • Strong understanding of regulatory affairs and pharmaceutical manufacturing processes.
  • Previous experience working in a regulatory role within the pharmaceutical or biotech industry.
  • Familiarity with TrackWise or similar regulatory tracking systems.
  • Excellent organizational and project management skills, with a keen attention to detail.
  • Effective communication and interpersonal skills to collaborate with both internal and external stakeholders.
  • Ability to prioritize tasks and manage time efficiently to meet tight deadlines.
  • Knowledge of regulatory requirements and guidelines, particularly in the pharmaceutical industry.
  • Proficiency in document management and data tracking.
  • Willingness to adapt to changing regulations and processes in the pharmaceutical industry.
  • Fluency in English and German (both written and spoken) is required.
  • Strong problemsolving skills and the ability to address regulatory challenges effectively.
  • Ability to work independently and as part of a crossfunctional team.
  • Knowledge of notarization, apostille, and legalization processes is a plus.

Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-qual

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