Head of Regional Competence Center

vor 3 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

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