IT Director Regulatory Affairs, Registration Eu

hace 1 semana

Barcelona, España Novartis A tiempo completo

**Summary**:
Our IT Director Regulatory Affairs Registration EU plays a pivotal role in our Development Organisation. In this role, you will lead critical IT Programs including the transformation of our Registration platform.

This role will have a direct global impact on Novartis products.

**About the Role**:
**Key Responsibilities**:

- Establish governance structure for the program with right customer representation for responsible Domain/functions. Track, report, and deliver against agreed success factors and KPIs for various customers for responsible Domain/functions.
- Accountable to Global Business Units for end-to-end Program delivery in the given sub-domain
- Drive programs that define & implement technology delivery strategy for business systems, platforms, and processes in partnership with senior business stakeholders & Strategic Business Partners.
- Actively participate in demand analysis, solution proposal/evaluation, and funding estimates for related projects/initiatives.
- Manage senior business stakeholders and collaboratively steer for consensus in making difficult & complex decisions.
- Manage interdependencies across products, looking for synergies and conflicts.
- Partner with relevant Technology Service/Solutions Delivery teams to ensure that the product and platform strategy balances the needs of Key Markets, need for reuse across other priority markets and cost effectively scale at speed to remaining midsize/small markets.
- Advocate for the business and customer strategy within the IT organization to steer Platform and Product investments, prioritization and decision-making.

**Key Requirements**:

- Excellent demonstrated experience in managing USD 50 Million+ programs involving senior business leaders in the Pharmaceutical or Life Science domain.
- Strong expertise in technical aspects of the Regulatory Affairs domain.
- Broad understanding of the larger Regulatory Affairs landscape, particularly Registration workflows and technical interdependencies within Registration streams including Clinical and Biomedical dataflows.
- Experience in multi-vendor delivery model and leadership of a multi-functional team within an Enterprise environment.
- Good understanding of agile methodology, product implementation, project governance with demonstrated ability to leverage emerging market trends.
- Fluency in English (written & oral).

**Desirable Requirements**:

- Pharmaceutical/Regulatory experience or experience in a related business domain.
- Veeva Certification or experience in Veeva platform implementation.
- Professional certifications such as PgMP/MSP, PMP/PRNCE2, Agile/SAFe or similar.

**Commitment to Diversity & Inclusion**:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

**Join our Novartis Network**:
Division

Operations

Business Unit

Universal Hierarchy Node

Location

Spain

Site

Barcelona Gran Vía

Company / Legal Entity

ES06 (FCRS = ES006) Novartis Farmacéutica, S.A.

Functional Area

Technology Transformation

Job Type

Full time

Employment Type

Regular

Shift Work

No

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