RA Senior Associate

Sandoz India; Telangana; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Sandoz India is seeking a Regulatory Information Management professional to manage data in Veeva Vault RIM, ensuring regulatory records are accurate and compliant. You will collaborate with Submission Management, Labeling, Publishing, Quality, and IT to implement regulatory processes and global standards.

The role requires strong analytical and problem-solving abilities, time management, and the capacity to influence stakeholders across global teams. Prior experience with XeVMPD/IDMP is a plus.

Qualifications

• Experience with Regulatory Information Management (RIM) systems.
• Strong knowledge of Veeva Vault RIM.
• Ability to work with cross-functional teams.
• Understanding regulatory processes and 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 company SOPs, regulatory requirements, and data governance standards.
• Work closely with Submission Management, Labeling, Publishing, Quality, and IT teams; lead cross-functional initiatives to implement regulatory processes and ensure global standards compliance.
• Support the implementation of regulatory initiatives like XeVMPD, IDMP, and others; maintain strong working knowledge of Veeva Vault systems.

Skills

Attention to detail

Analytical thinking

Stakeholder management

Time management

Cross-functional collaboration

Tools

Veeva Vault

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.

• 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.

#Sandoz