RA Senior Associate

2 years

0 Lacs

Posted:6 hours ago| Platform: GlassDoor logo

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Work Mode

On-site

Job Type

Part Time

Job Description

Your Key Responsibilities:

Your responsibilities include, but not limited to:

  • Lead as the support for Veeva Vault RIM modules like Registrations, Submissions and Submissions archival.
  • Provide training, SOP updates, and ongoing system support to regulatory users and stakeholders.
  • Monitor system performance and proactively identify opportunities for improvement or automation. Collaborate with stakeholders to gather and document detailed system requirements for enhancement aligned to business processes and GxP compliance. Ensure compliance with industry standards and regulations in all system implementations.
  • Utilize analytical skills to interpret data and provide actionable insights for decision-making. Drive continuous improvement initiatives to streamline processes.
  • Ensure the integrity and accuracy of regulatory data within Veeva Vault, including product information, submission statuses, and regulatory milestones.
  • Stay updated on regulatory changes and ensure that the organization’s processes and systems comply with current regulations and industry best practices.
  • Identify areas for improvement and implement solutions to optimize the use of Veeva Vault. Act as a subject matter expert and provide guidance on Veeva Vault to other departments.
  • Continuously seek opportunities to enhance and expand your knowledge and skills in Veeva Vault and related technologies.

What you’ll bring to the role:

Essential Requirements:

  • 2+ years of experience is a must
  • Good knowledge of Regulatory Affairs processes
  • Knowledge of Regulatory guidelines is a plus.
  • Ability to work under pressure, demonstrating initiative and flexibility
  • Attention to detail and quality focused.
  • Team spirit and embracing diversity of cultures and personalities.

Skills :

  • RIMS Veeva vault
  • Documentation Management
  • Operational Excellence
  • Business process optimization
  • Quality and Compliance
  • Teamwork
  • Adaptability

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients 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, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!

Join us!


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Sandoz

Pharmaceuticals

Basel

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