Specialist - RA

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!
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 & 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 unit customers.

Job Description

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Manages medium to small level global regulatory submission projects.
• 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.
• Frequent internal company and external contacts.
•  Represents organization on specific projects -Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
• Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt -Distribution of marketing samples (where applicable)
   

What you’ll bring to the role:

Essential Requirements:

• Cross Cultural Experience.
• 5+ years of relevant experience.
• Functional Breadth.
• Collaborating across boundaries.
• Operations Management and Execution.
• Project Management.
   

 Skills:

• Clinical Study Reports.
• Data Analysis.
• Documentation Management.
• Lifesciences.
• Operational Excellence.
• Regulatory Compliance.

 

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!

Skills Desired

Clinical Study Reports, Data Analysis, Documentation Management, Lifesciences, Operational Excellence, Regulatory Compliance

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