Regulatory Compliance Expert

vor 3 Wochen

Kundl, 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 pre-evaluation 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-8107006), 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 follow-up’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 stock-out 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 problem-solving skills and the ability to address regulatory challenges effectively.
- Ability to work independently and as part of a cross-functional 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

  • Regulatory Compliance Expert

    vor 1 Woche

    Kundl, Tirol, Österreich Sandoz GmbH Vollzeit

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

  • QA Compliance Expert

    vor 1 Woche

    Kundl, Tirol, Österreich Novartis Vollzeit

    393594BRQA Compliance Expert - Reg CMC Facilitator:AustriaAbout the roleQA Compliance Expert - Reg CMC FacilitatorSupporting product maintenance, and activities throughout the product life-cycle using regulatory strategies and documents related to CMC (Chemistry, Manufacturing & Control). This applies to sector-specific (global and local) products and is...

  • QA Compliance Expert

    vor 2 Monaten

    Kundl, Österreich Novartis Vollzeit

    393594BR **QA Compliance Expert - Reg CMC Facilitator**: Austria **About the role** **QA Compliance Expert - Reg CMC Facilitator** Supporting product maintenance, and activities throughout the product life-cycle using regulatory strategies and documents related to CMC (Chemistry, Manufacturing & Control). This applies to sector-specific (global and...

  • QA Compliance Expert Medical Device

    vor 1 Woche

    Kundl, Tirol, Österreich Novartis Vollzeit

    QA Compliance Expert Medical Device (f/m/d), Quality, Kundl, Austria160 Million This is the number of antibiotics packs that we produce in Kundl and deliver to patients in more than 80 countries all over the world in a year Your role will be to ensure that the site maintains alignment with the local legislation (AMBO), EU directives and FDA guidelines. As QA...

  • QA Compliance Expert Medical Device

    vor 2 Monaten

    Kundl, Österreich Novartis Vollzeit

    **QA Compliance Expert Medical Device (f/m/d), Quality, Kundl, Austria** 160 Million! This is the number of antibiotics packs that we produce in Kundl and deliver to patients in more than 80 countries all over the world in a year! Your role will be to ensure that the site maintains alignment with the local legislation (AMBO), EU directives and FDA...

  • QA Compliance Expert

    vor 1 Woche

    Kundl, Tirol, Österreich Sandoz GmbH Vollzeit

    QA Compliance Expert (d/f/m), Kundl, Tyrol, Austria - Part-Time 75%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...

  • QA Compliance Expert

    vor 1 Woche

    Kundl, Tirol, Österreich Sandoz GmbH Vollzeit

    QA Compliance Expert (d/f/m), Kundl, Tyrol, AustriaSandoz 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...

  • Regulatory Affairs Manager

    vor 3 Wochen

    Kundl, Tirol, Österreich Randstad Vollzeit

    Du verfügst über eine Affinität für IT-Systeme und bist im Projektmanagment ein Profi?Dann könnte die Sandoz GmbH das Richtige für dich sein Zur Verstärkung des Teams suchen wir ab sofort in Kundl im Tiroler Unterland eine/n: Regulatory Affairs Manager (m/w/d) - Regulierungsysteme / Compliance Das Aufgabengebiet umfasst folgende Tätigkeiten:Leitung...

  • Regulatory Affairs Manager

    vor 2 Monaten

    Kundl, Tirol, Österreich Randstad Vollzeit

    Du verfügst über eine Affinität für IT-Systeme und bist im Projektmanagment ein Profi?Dann könnte die Sandoz GmbH das Richtige für dich sein Zur Verstärkung des Teams suchen wir ab sofort in Kundl im Tiroler Unterland eine/n: Regulatory Affairs Manager (m/w/d) - Regulierungsysteme / Compliance Das Aufgabengebiet umfasst folgende Tätigkeiten:Leitung...

  • QA Compliance Expert

    vor 3 Wochen

    Kundl, Österreich Sandoz GmbH Vollzeit

    **QA Compliance Expert (d/f/m), Kundl, Tyrol, Austria - Part-Time 75%** 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...

  • QA Compliance Expert

    vor 3 Wochen

    Kundl, Österreich Sandoz GmbH Vollzeit

    **QA Compliance Expert (d/f/m), 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,...

  • Manager Regulatory Affairs

    vor 1 Woche

    Kundl, Tirol, Österreich Sandoz GmbH Vollzeit

    Manager Regulatory Affairs (d/f/m), Kundl, Tyrol, Austria8 This is the number of high-quality biosimilars for which Sandoz has already received a marketing authorization, and that provided increased access to life-saving medicines to patients worldwide. Additionally, Sandoz has a rich pipeline of further biosimilars under development. As a Manager Regulatory...

  • Manager Regulatory Affairs

    vor 3 Wochen

    Kundl, Österreich Sandoz GmbH Vollzeit

    **Manager Regulatory Affairs (d/f/m), Kundl, Tyrol, Austria** 8! This is the number of high-quality biosimilars for which Sandoz has already received a marketing authorization, and that provided increased access to life-saving medicines to patients worldwide. Additionally, Sandoz has a rich pipeline of further biosimilars under development. As a Manager...

  • Regulatory Affairs Associate

    vor 1 Woche

    Kundl, Tirol, Österreich Sandoz Vollzeit

    Your key responsibilities:Your responsibilities include, but are not limited to:Support activities and documentation necessary for Biosimilars submissions and product maintenance worldwide throughout lifecycle of the product (incl. variations, renewals, Periodic Safety Update Reports). Manage the interaction with DRA colleagues in country organizations (COs)...

  • Regulatory Affairs Associate

    vor 1 Woche

    Kundl, Österreich Sandoz Vollzeit

    **Your key responsibilities**: Your responsibilities include, but are not limited to: - Support activities and documentation necessary for Biosimilars submissions and product maintenance worldwide throughout lifecycle of the product (incl. variations, renewals, Periodic Safety Update Reports). - Manage the interaction with DRA colleagues in country...

  • QA Operations Expert

    vor 1 Woche

    Kundl, Tirol, Österreich Novartis Vollzeit

    385834BRQA Operations Expert (f/m/d):AustriaAbout the roleQA Operations Expert (w/m/d), Kundl, ÖsterreichAs a QA Operations Expert you will be crucial in supporting our mission to supply more than 22 different high quality Biopharmaceutical Products to patients worldwide.Your Responsibilities: Oversight of all production & testing activities, ensures...

  • QA Operations Expert

    vor 3 Wochen

    Kundl, Österreich Novartis Vollzeit

    385834BR **QA Operations Expert (f/m/d)**: Austria **About the role** **QA Operations Expert (w/m/d), Kundl, Österreich** As a QA Operations Expert you will be crucial in supporting our mission to supply more than 22 different high quality Biopharmaceutical Products to patients worldwide. **Your Responsibilities**: - Oversight of all production &...

  • QA Operations Expert

    vor 3 Wochen

    Kundl, Österreich Novartis Vollzeit

    389521BR **QA Operations Expert (f/m/d)**: Austria **About the role** **QA Operations Expert (w/m/d), Kundl, Austria** As a QA Operations Expert you will be crucial in supporting our mission to supply more than 22 different high quality Biopharmaceutical Products to patients worldwide. **Your Responsibilities**: - Oversight of all production & testing...

  • Associate Expert Downstream Processing

    Vor 7 Tagen

    Kundl, Österreich Novartis Vollzeit

    393071BR **Associate Expert Downstream Processing**: Austria **About the role** **About the role** **Associate Expert Science & Technology(f/m/d),** **Tyrol, Austria, #LI-Hybrid.** Our Downstream Development Team is responsible for the development and transfer of processes and thus a key part for bringing new, innovative, biopharmaceutical drugs to the...

  • Registration Manager

    vor 3 Wochen

    Kundl, Österreich Sandoz GmbH Vollzeit

    **Registration Manager (d/f/m), 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,...