Regulatory Compliance Expert

vor 5 Monaten

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

  • QA Compliance Expert

    vor 5 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...

  • Regulatory Affairs Specialist

    vor 4 Wochen

    Kundl, Tirol, Österreich Novartis Vollzeit

    Job Description SummarySandoz is undergoing a transformative period as a global leader in sustainable Generic and Biosimilar medicines.Key Responsibilities:Develop and lead global CMC regulatory strategies, balancing business benefits with regulatory compliance.Lead and implement global CMC submission activities, including planning, authoring, reviewing,...

  • QA Compliance Expert

    Vor 2 Tagen

    Kundl, Österreich Novartis Vollzeit

    **Summary**: QA Compliance Expert (m/w/d) Location: Kundl, Tirol, Österreich #LI-Hybrid 40 Jahre! So lange werden an der Site “Drug Substance Kundl" erfolgreich Proteine mit mikrobieller Fermentation hergestellt. Zusätzlich wurde in den vergangenen Jahren in einer neuen Produktklasse Fuß gefasst: Nukleinsäuren z.B. für den zell - und...

  • QA Compliance Expert

    vor 5 Monaten

    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 5 Monaten

    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 5 Monaten

    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...

  • Global GMP Auditor

    Vor 6 Tagen

    Kundl, Tirol, Österreich Novartis Vollzeit

    Job Description: We are seeking a Global GMP Auditor - Compliance Specialist to join our Team. As a Global GMP Auditor - Compliance Specialist, you will be responsible for leading, planning, and conducting GMP audits to ensure compliance with regulatory requirements. Your key responsibilities will include executing audits according to the audit schedule,...

  • Regulatory Affairs Associate

    vor 5 Monaten

    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...

  • Regulatory Drug Substance Manager

    vor 4 Wochen

    Kundl, Österreich Sandoz Vollzeit

    **Your responsibilities include, but are not limited to**: - Formulate and lead global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance - Lead and implement global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. - Identify the...

  • Quality Assurance Expert

    vor 4 Wochen

    Kundl, Tirol, Österreich Novartis Vollzeit

    Job Description SummaryAs a Quality Assurance Operations Expert at Novartis, you will be responsible for ensuring that all production and testing activities in your area of responsibility are executed according to cGxP standards. This includes oversight of all production and testing activities, ensuring compliance with cGxP, including data integrity and...

  • Global GMP Quality Compliance Specialist

    Vor 4 Tagen

    Kundl, Tirol, Österreich Novartis Vollzeit

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

  • QA Operations Expert

    vor 5 Monaten

    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...

  • QA Operations Expert

    vor 5 Monaten

    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 &...

  • Associate Expert Downstream Processing

    vor 5 Monaten

    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...

  • Senior Technical Manager for Aseptics

    vor 1 Monat

    Kundl, Tirol, Österreich Novartis Vollzeit

    About the RoleSandoz is embarking on an exciting transformation as a global leader in sustainable Generic and Biosimilar medicines. As an independently listed company, we aim to increase our strategic focus, operate with greater agility, and strengthen our culture for our associates.In this role, you will play a crucial part in implementing new aseptic...

  • QA Operations Expert

    vor 1 Monat

    Kundl, Österreich Novartis Vollzeit

    **Summary**: QA Operations Expert ensures QA Operation activities in the area of responsibility are executed according to cGxP standards. **About the Role**: **Major accountabilities**: - Oversight of all production & testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance - Participation in the preparation and approval of...

  • Senior Technical Manager for Aseptics

    vor 10 Stunden

    Kundl, Tirol, Österreich Novartis Vollzeit

    New Opportunities in Aseptic ManufacturingSandoz, a global leader in sustainable generic and biosimilar medicines, is undergoing a transformative period. As an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, and enhance shareholder returns.This role plays a crucial part in implementing new aseptic...

  • Senior Mass Spectrometry Expert

    vor 5 Monaten

    Kundl, Österreich Novartis Vollzeit

    393784BR **Senior Mass Spectrometry Expert - Analytical Characterisation (M/F/d)**: Austria **About the role** Location: Kundl, Austria Role Purpose: “Knowledge is key - and I can provide you with that knowledge!” - Do you identify with this credo? Can you live up to the challenge by supplying excellent knowledge on biopharmaceutical focused mass...

  • Registration Manager

    vor 5 Monaten

    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,...

  • Registration Manager

    vor 5 Monaten

    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,...