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:

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.

• Develop and provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products

• May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers.

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

• Manages multiple, large and complex global regulatory submission projects.

• 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

• 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.

Ensures compliance to the requirements from regulatory agencies.

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
What You’ll bring to the role:

• University or College Degree in any field or life science with relevant industry experience or comparable degree

• At a minimum 8 years’ experience in the Pharmaceutical area, specifically in Regulatory Operations with People Management experience

• Experience in the Regulatory submission publishing, area is preferred. Knowledge of Regulatory guidelines for the areas mentioned above

• Organizational awareness and experience working cross-functionally and in global teams is a plus

• Ability to work under pressure, demonstrating initiative and flexibility

• Attention to detail and quality focused

• Team-minded

Why consider Sandoz?

Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?

The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.

Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

Imagine what you could do at Sandoz!

Commitment to Diversity & Inclusion:

Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Group Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Division
SANDOZ
Business Unit
Product Dev SZ
Country
India
Work Location
Hyderabad, AP
Company/Legal Entity
Nov Hltcr Shared Services Ind
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No