Gl.assoc.dir.sol.delivery Regulator Affairs

2 months ago

Hyderabad Telangana, India Novartis Full time

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
The role is leading service delivery for a business area/sub capability of the company across all geographies. Accountable to Global Business Units for end-to-end project delivery and/or operations in the given sub-domain/sub-capability. Partner with Business Stakeholders (GPO) and Technology teams for demand analysis,
solution proposal/evaluation and project delivery.
Your responsibilities include but not limited to:

- Support strategic evolution of high priority Regulatory Affairs products (incl. RIM, Document Mgmt, Submission Mgmt, Labelling, etc.) building efficient and sustainable solutions meeting customer needs and business goals.
- Define and implement technology delivery strategy for business systems, platforms, and processes for responsible business domain/function(s)
- Partner with senior business customers and technology teams for demand analysis, solution proposal/evaluation, and funding estimates. Partner with vendors to keep abreast with upgrades, changes and latest technology
- Ensure on time, within budget, compliant, secure, and quality delivery of portfolio for responsible Business domain / functions. Ensure services, solutions, products are fit for purpose and achieve the desired business value and impact
- Establish governance structure for projects, operations, etc. 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
- Follow industry trends and emerging practices to drive agility, speed, efficiency, and effectiveness. Ensure the overall user experience is taken into account when designing deploying new solutions and services
- Take accountability to ensure alignment to Security and Compliance policies and procedures. If required, lead projects/products following Agile and other relevant PM practices

**Commitment to Diversity & Inclusion**:

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

**Minimum requirements**
- Good understanding of Regulatory Affairs business processes and requirements (IDMP / SPOR, eCTD, xEVMPD, SPL / SPM, etc.)
- 5 years+ of industry experience in IT, healthcare, or pharma; expert understanding of technology and methodologies as applied in the respective area. Multi-national global experience
- Excellent Functional experience in pharmaceutical development domains combined with build & run of Digital & IT solutions
- Experience in leading products and handling diverse group of stakeholders
- Experience and understanding of Agile product development
- Deep knowledge of IT & business processes and experience in validated environments (GxP)
- Ability to communicate effectively with senior management, handle issues, resolve conflicts, and mitigate risks.High display of Sandoz Values & Behaviors

ORBIT

Why Sandoz?

500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying

Imagine what you could achieve here at Sandoz

Commitment to Diversity & Inclusion:
Sandoz is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and accommodation

**Division**

Operations

**Business Unit**

NTO SANDOZ TECHOPS

**Country**

India

**Work Location**

Hyderabad, AP

**Company/Legal Entity**

Sdz Pvt Ind

**Functional Area**

Technology Transformation

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

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