Head of Regional Competence Center

vor 2 Wochen

Munich, Deutschland Novartis Vollzeit

2023 will see Sandoz become a standalone organization As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength Those joining Sandoz in the coming months will help shape the future of the company, it’s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact This is one such role

**Are you ready to make a difference?**

**Role Purpose**

The Sandoz Regulatory Competence Centre (RCC) - SIR (RCC-SIR), is located in Holzkirchen, Germany.
The RCC teams in Germany, in the offices of Sandoz GmBH - coordinating all new submissions of the company for all SIR markets (LATAM and APMA) bar Japan.
The main task of the RCC-SIR is to manage the Centre teams that are responsible for all drug regulatory affairs matters in the regions and countries of SIR and act as an interface between the business development licensing/development/maintenance regulatory centers, country organizations and SIR authorities.
The RCC’s role is to be a strategic partner, being the SPOC for regulatory topics for all other stakeholders at regional level, capable of developing a regional strategy, local market strategy and submission plan; formulating and working on Regulatory Policy and Compliance topics. The RCC Head needs to co-ordinate dossier preparation and submission, answering of questions and ensuring local approvals in market. To do this the Head must know local and regional requirements sufficiently to enable global functions to prepare RFT Biosimilar and SM dossiers.
The RCC-SIR teams (LATAM and APMA) in Germany consist of 28 persons.
The Head RCC SIR is reporting solid line to the Head Global Drugs Regulatory Affairs and dotted line to the Region Head SIR.

**Your Key Responsibilities**
- Formulate and determine the region specific regulatory strategic according to the Sandoz Global Development strategy in line with above and within country functions
- Execute into operational targets and monitor the realization of the policy and targets.
- To set targets fitting the strategies of the SIR and to develop strategies to reach these targets.
- To implement and maintain an effective SIR registration strategy which ensures timely registrations and regulatory ability to launch of products in relevant countries.
- To draw up and ensure compliance with budgets for costs and investments
- to ensure that all registration projects proceed as planned, observing development and needs for changing the plans
- to ensure that all projects proceed as planned (i.e. monitor the progress of technical and clinical development, and of the preparation of files)
- lead the associates to determine registration strategies
- lead the associates to coordinate new approval procedures as well as renewals and variations (maintenance)
- lead the associates to organize documents etc. that are necessary for new submissions and maintenance of existing marketing authorizations, and are submitted to the authorities, either by the RCC directly or by the relevant country organizations
- to determine, implement and keeping the structures, instruments, means and procedures current and efficient
- to define, quantify, assign and control tasks and projects
- to ensure right-size organization and associate(s)
- to ensure availability of in-house state-of-the-art professional know-how regarding pharmaceutical development, dossier compilation and SIR regulatory affairs

**Commitment to Diversity & Inclusion**:

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

**Minimum requirements**
- Life-science studies and expert knowledge of regulatory affairs processes.
- A minimum of ten years work in the Regulatory Affairs in the pharmaceutical industry and a minimum of five years in a coordinating/directing role (leadership role).
- Project and solution-oriented working and thinking, focused on relationships and the achievement of ambitious goals
- Has vision, determines the performance required to achieve his or her own objectives and those of the department and the organisation, sets ambitious goals and makes difficult decisions.

**Division**

SANDOZ

**Business Unit**

Sandoz Global Development

**Country**

Germany

**Work Location**

Holzkirchen (near Munich)

**Company/Legal Entity**

Sandoz International

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

  • Head of HR Competence Center

    vor 2 Wochen

    Munich, Deutschland Delphi HR-Consulting Vollzeit

    Unser Mandant ist ein herstellerunabhängiger Anbieter von Full-Service-Leasing und mit seinen Mobilitätslösungen seit über 30 Jahren weltweit führend. Bis Ende letzten Jahres wurden weit über eine Millionen Fahrzeuge verleast. Mehr als 7500 Mitarbeiter ermöglichen in rund 30 Ländern ein flexibles und zugleich optimales Reisen für das vielfältige...

  • Consultant Center of Competence Internal Audit

    vor 2 Monaten

    Munich, Bayern, Deutschland Deloitte Germany Vollzeit

    Consultant Center of Competence Internal Audit (m/w/d) Das Center of Competence Internal Audit betreut sowohl die Jahresabschlussprüfungen der Revisionen als auch die Revisionen unserer Mandantschaft und bietet dazu eine mandatsspezifische Auftragskoordination auch bei Co-Sourcing durch einen festen Ansprechpartner aus dem Center of Competence Internal...

  • Consultant Center of Competence Internal Audit

    Vor 4 Tagen

    Munich, Bayern, Deutschland Deloitte Germany Vollzeit

    Consultant Center of Competence Internal Audit (m/w/d) Das Center of Competence Internal Audit betreut sowohl die Jahresabschlussprüfungen der Revisionen als auch die Revisionen unserer Mandantschaft und bietet dazu eine mandatsspezifische Auftragskoordination auch bei Co-Sourcing durch einen festen Ansprechpartner aus dem Center of Competence Internal...

  • Consultant Center of Competence Internal Audit

    vor 3 Wochen

    Munich, Bayern, Deutschland Deloitte Germany Vollzeit

    Consultant Center of Competence Internal Audit (m/w/d) Das Center of Competence Internal Audit betreut sowohl die Jahresabschlussprüfungen der Revisionen als auch die Revisionen unserer Mandantschaft und bietet dazu eine mandatsspezifische Auftragskoordination auch bei Co-Sourcing durch einen festen Ansprechpartner aus dem Center of Competence Internal...

  • Talent Management

    vor 2 Monaten

    Munich, Deutschland STMicroelectronics Vollzeit

    Position description **Posting title**: - Talent Management - Head of Regional E2E Talent Management, EMEA M/F **Regular/Temporary**: - Regular **Job description**: - *Accountabilities and responsibilities* - Tailor the global talent strategies by considering EMEA regional & local circumstances. - Oversee and coordinate all talent related activities...

  • Consultant Center of Competence Internal Audit

    vor 3 Wochen

    Munich, Deutschland Deloitte Germany Vollzeit

    Consultant Center of Competence Internal Audit (m/w/d) Das Center of Competence Internal Audit betreut sowohl die Jahresabschlussprüfungen der Revisionen als auch die Revisionen unserer Mandantschaft und bietet dazu eine mandatsspezifische Auftragskoordination auch bei Co-Sourcing durch einen festen Ansprechpartner aus dem Center of Competence Internal...

  • Consultant Center of Competence Internal Audit

    vor 2 Monaten

    Munich, Deutschland Deloitte Germany Vollzeit

    Consultant Center of Competence Internal Audit (m/w/d) Das Center of Competence Internal Audit betreut sowohl die Jahresabschlussprüfungen der Revisionen als auch die Revisionen unserer Mandantschaft und bietet dazu eine mandatsspezifische Auftragskoordination auch bei Co-Sourcing durch einen festen Ansprechpartner aus dem Center of Competence Internal...

  • Head (F/m/d) of Center of Expertise HR

    vor 1 Woche

    Munich, Deutschland Siemens Vollzeit

    **We are on the journey of building the new motors and large drives company Innomotics and are therefore looking for a global **_Head (f/m/d) of Center of Expertise (CoE) HR_** to join our team at Innomotics.** **Launch of our new company Innomotics** We are on the exciting journey of forming a new leading motors and large drives company - Innomotics....

  • Head of Group Accounting

    Vor 4 Tagen

    Munich, Deutschland valantic GmbH Vollzeit

    **München** **Berufserfahrene** **Dein Wirkungsfeld**: Als Head of Group Accounting (all genders) arbeitest Du in der Schnittstelle zwischen CFO, Controlling, Tax, Wirtschaftsprüfern und den Buchhaltern und Steuerberatern bzw. Finance-Verantwortlichen unserer Tochtergesellschaften (Competence Center) im Inland und Ausland. Das Team Group Accounting...

  • Regional Head Munich

    vor 2 Monaten

    Munich, Deutschland Salesforce Vollzeit

    **Job Category **:Sales **Job Details**: **Regional Heads/HUB Leaders Germany**: **Job Details**: The strength of Germany comes from a federalist structure which has evolved over thousands of years. Culture, Politics and the economy are fundamentally organized around multiple regions. Salesforce has decided to significantly increase the investments to...

  • Head of Regional Market Development

    vor 2 Monaten

    Munich, Deutschland Carl Remigius Fresenius Education AG Vollzeit

    **Head of Regional Market Development (m/w/d)**: - Standort Köln Düsseldorf Frankfurt Idstein München Wiesbaden - Abteilung Vertrieb - Anstellungsart Full-time - Unternehmen Carl Remigius Fresenius Education AG - Startseite - Head of Regional Market Development (m/w/d) Menschen mit Bildung zu inspirieren und sie auf die Chancen und Herausforderungen der...

  • Head of Regional Market Development

    vor 1 Woche

    Munich, Deutschland Hochschulen Fresenius GmbH Vollzeit

    **Head of Regional Market Development (m/w/d)**: - Standort Düsseldorf Frankfurt Idstein Köln München Wiesbaden - Abteilung Vertrieb - Anstellungsart Vollzeit - Unternehmen Hochschulen Fresenius GmbH - Startseite - Head of Regional Market Development (m/w/d) Menschen mit Bildung zu inspirieren und sie auf die Chancen und Herausforderungen der Zukunft...

  • Head of Digital Innovation

    vor 2 Wochen

    Munich, Deutschland ZEISS Group Vollzeit

    Purpose of the Job The Head of Digital Innovation is responsible for promoting, driving and delivering the innovation strategy of the Digital Health Center of Excellence (CoE), leading a team of innovation managers and data scientists responsible for the delivery of Proof of Feasibility in the field of software projects. Focus on generating software...

  • Volontariat Competence Center Health

    Vor 3 Tagen

    Munich, Bayern, Deutschland Hubert Burda Media Vollzeit

    **Volontariat Competence Center Health (m/w/d)**:Deutschlands großes Kompetenzzentrum für Gesundheitsthemen (FOCUS Gesundheit, MyLife, ,) und die Burda Journalistenschule (BJS) bieten dir ein journalistisches Volontariat in einem der größten Media- und Tech-Unternehmen Deutschlands. Die zweijährige Ausbildung gehört zu den modernsten des Landes. Sie...

  • Head of Strategic HR Leadership

    vor 2 Wochen

    Munich, Deutschland Delphi HR-Consulting Vollzeit

    Unser Mandant ist ein herstellerunabhängiger Anbieter von Full-Service-Leasing und mit seinen Mobilitätslösungen seit über 30 Jahren weltweit führend. Bis Ende letzten Jahres wurden weit über eine Millionen Fahrzeuge verleast. Mehr als 7500 Mitarbeiter ermöglichen in rund 30 Ländern ein flexibles und zugleich optimales Reisen für das vielfältige...

  • Regional Head of Clinical Operations, Northern

    vor 2 Wochen

    Munich, Deutschland Bristol-Myers Squibb Vollzeit

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Head of Data

    vor 3 Wochen

    Munich, Bayern, Deutschland Yoummday GmbH Vollzeit

    Head of Data (m/w/d) Permanent employee, Full-time · München DeutschSee all positions About us You made my day a daymaker Take advantage of the opportunity to help us revolutionise the contact centre industry... We are a game changer - innovative, contemporary and different. A company where it's fun to be a customer, a talent but also an employee. At...

  • Head of Data

    vor 2 Monaten

    Munich, Bayern, Deutschland Yoummday GmbH Vollzeit

    Head of Data (m/w/d) Permanent employee, Full-time · München DeutschSee all positions About us You made my day a daymaker Take advantage of the opportunity to help us revolutionise the contact centre industry... We are a game changer - innovative, contemporary and different. A company where it's fun to be a customer, a talent but also an employee. At...

  • Head of Division

    vor 1 Monat

    Munich, Bayern, Deutschland Munich Re Vollzeit

    The Group Investment Management (GIM) division is responsible for managing the proprietary Munich Re and ERGO investment portfolio of around €240bn. We are looking for an accomplished leader for the role of the Head of Group Investment Steering. The business unit responsibilities are divided in three departments: Investment Steering Primary Insurance LH...

  • Head of Division

    vor 3 Wochen

    Munich, Bayern, Deutschland Munich Re Vollzeit

    The Group Investment Management (GIM) division is responsible for managing the proprietary Munich Re and ERGO investment portfolio of around €240bn. We are looking for an accomplished leader for the role of the Head of Group Investment Steering. The business unit responsibilities are divided in three departments: Investment Steering Primary Insurance LH...