RA Senior Associate

IN04 (FCRS = IN004) Sandoz Private Limited; Telangana; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Sandoz is a global leader in biosimilar and generic medicines. The Senior Associate provides SME in Regulatory Information Management (RIM) and ensures accurate regulatory data management while supporting end users and data governance.

The role collaborates with cross-functional teams, monitors data quality, and drives process improvements to enable efficient regulatory operations, with emphasis on Veeva Vault RIM and related initiatives.

Qualifications

• Data analysis and documentation management skills.
• Experience with regulatory operations or governance.

Responsibilities

• Maintain and manage data within Regulatory Information Management (RIM) systems like Veeva Vault.
• Create, update, and maintain regulatory records within Veeva Vault RIM.
• Ensure activities comply with SOPs, regulatory requirements, and data governance standards.
• Collaborate with Submission Management, Labeling, Publishing, Quality, and IT teams.
• Lead cross-functional initiatives to implement regulatory processes and ensure compliance with global standards.
• Support regulatory initiatives like XeVMPD and IDMP.
• Demonstrate strong analytical, problem-solving, and stakeholder-influence abilities.

Skills

Data Analysis

Documentation Management

Operational Excellence

Tools

Veeva Vault

Job description

Job Description Summary

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape! The Senior associate provides subject matter expertise in Regulatory Information Management (RIM) systems and processes within Global Regulatory Affairs (GRA). This role ensures accurate regulatory data management, supports end users, monitors data quality, and drives continuous process and system improvements to facilitate efficient regulatory operations. Acting as a subject matter expert (SME) in Veeva RIM Vault, the Senior Associate will collaborate with cross-functional teams, support process implementation, and develop training, if required, to ensure teams are equipped to meet evolving regulatory demands.

Job Description Major accountabilities

Maintain and manage data within Regulatory Information Management (RIM) systems like Veeva Vault. Create, update, and maintain regulatory records within Veeva Vault RIM. Ensure activities comply with company SOPs, regulatory requirements, and data governance standards. Work closely with Submission Management, Labeling, Publishing, Quality, and IT teams. Lead and collaborate on cross-functional initiatives to implement regulatory processes, ensuring compliance with global standards Support the implementation of regulatory initiatives like XeVMPD, IDMP, and others. Strong working knowledge of Veeva Vault systems. Good time management, prioritization, and attention to detail. Strong analytical, problem-solving, and critical-thinking abilities. Ability to influence stakeholders across different levels in global teams.

Why Sandoz?

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health. With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably. Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported! Join us, help us make healthcare fairer and faster.

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.

Skills Desired

Data Analysis, Documentation Management, Operational Excellence

Our Purpose here at Sandoz

Here at Sandoz is pioneering access for patients. As the global leader in ‘off-patent’ high quality medicines, we are able to make medicine more affordable and accessible. Our broad global portfolio comprises of approximately 1,300 quality biosimilar and generic medicines, enabling us to provide more than 900 million patient treatments across 100+ countries per year, and while we are proud of this achievement, we have an ambition to do more! Powered by our talented and ambitious colleagues, who, in return for dedication and skills, experience a flexible, collaborative & inclusive culture where diversity of thought is welcomed and where personal growth is nurtured!