Senior Specialist

Job Description

1886! We have more than 130 years of experience treating patients.
Sandoz, a division of Novartis, is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide.

Your responsibilities include but not are limited to:

• Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements.

• Ensures compliance to the requirements from regulatory agencies.

• Maintains the technical and non-technical documentation change system.

• Assures procedures are in place to classify and maintain records.

• Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements. May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers.

• May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched.

• May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers.

Diversity & Inclusion / EEO

Novartis is 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:

• Manages multiple, large and complex global regulatory submission projects. Develop and provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products.

• Contribute to strategic and technical input/support to drive implementation of global systems, tools and processes to support global development projects and/or marketed products.

• A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.

• This job is the fully qualified, career-oriented, journey-level position . -Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.

• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.

• Networks with senior internal and external personnel in own area of expertise.

• Contributes to many cost center goals and objectives; may contribute to service line goals.

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