Reg Affairs Associate; Documentation

Posted 6 Hours Ago
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Sandoz, CA, USA
In-Office
Entry level
Biotech • Pharmaceutical
The Role
The role involves managing documentation, ensuring compliance with regulatory requirements, and communicating documentation standards while maintaining records and data analysis.
Summary Generated by Built In

Job Description Summary

-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 & maintain records. Interprets and 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

Major accountabilities: 

  • Learns to use basic principals, theories, and professional concepts.
  • Contacts are primarily with immediate supervisor and other personnel in department or group -Works on problems of routine scope.
  •  Follows established policies and procedures.
  • Normally receives detailed instructions on all work -Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt -Distribution of marketing samples (where applicable)

 

Key performance indicators:

  • Adherence to Sandoz policy & guidelines -Project & stakeholder feedback

 Minimum Requirements: 
 

  Work Experience:

  • Cross Cultural Experience.
  • Collaborating across boundaries.
  • Operations Management and Execution.
     
  •  Skills:
  • Data Analysis.
  • Documentation Management.
  • Operational Excellence.
     

 Languages :

  • English.

Skills Desired

Data Analysis, Documentation Management, Operational Excellence

Skills Required

  • Cross Cultural Experience
  • Collaborating across boundaries
  • Operations Management and Execution
  • Data Analysis
  • Documentation Management
  • Operational Excellence
  • English proficiency

Sandoz Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Sandoz and has not been reviewed or approved by Sandoz.

  • Healthcare Strength Health, dental, vision, and prescription coverage are consistently described as core components across U.S. roles and materials. Feedback suggests the medical offering is broad and a standard pillar of the package.
  • Retirement Support A 401(k) plan with a company match described as generous is commonly included for U.S. roles. This savings support is positioned alongside other primary benefits as part of total rewards.
  • Equity Value & Accessibility Equity eligibility is noted for many positions and a global all‑employee share program is being introduced from 2026. These elements add upside beyond base salary and annual bonus.

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The Company
HQ: Basel
17,135 Employees

What We Do

Sandoz is the global leader in generic and biosimilar medicines. ​ ​Our Purpose is to pioneer access to medicines for patients globally. We are on a mission to drive innovation in the healthcare industry by freeing up resources sustainably and responsibly while continuing to address global health challenges such as antimicrobial resistance.​ We are present in more than 100 countries and our medicines serve some 500 million people every year. We have two main global businesses: Generics - divided between standard generics and complex generics - and Biosimilars.

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