Job Description Summary
Join us, the future is ours to shape!Job Description
The Operations Publishing team is responsible for the delivery of published output which fulfils the technical and format requirements of the Health Authorities and is dispatched and / or submitted to the authorities according to given timelines and in high quality. of regulatory application cluster in terms of first level issue, change and user management.
The RA Specialist's overall purpose is to:
Ensure preparation, validation, dispatch and submission of compliant and high quality initial, 2nd wave and maintenance Regulatory filings according to submission plans.
Update respective Regulatory systems for Registration Management, Publishing and Document Management.
Support the Global Regulatory teams during the product development phase and provide input as appropriate
Follow Regulatory procedures and timelines
Your Key Responsibilities:
Your responsibilities include, but not limited to:
Support regulatory teams during the submission process in all administrative and technical steps according to global procedures
Prepare and dispatch/submit documentation packages for predefined submission types and region(s) in compliance with Health Authority requirements
Ensure eCTD lifecycle maintenance according to ICH and regional specifications
Ensure timely update of submission data in the regulatory information management databases and verify that the data is kept compliant
Be involved in the timely and efficient processing of regulatory, submission-relevant documents like M1, eApplication Form, COPPs, GMP Certificates
Maintain communication network with regulatory functions like RCCs, MRCc and country organizations and non-regulatory stakeholders according to guidance documents
Ensure escalation procedures are followed in case of issues and delays
Assist with document preparation activities such as scanning, bookmarking, hyperlink creation, and quality checks to ensure submission readiness
Support large-scale document upload and management activities
What you’ll bring to the role:
Essential Requirements:
University or College Degree in any field or life science with relevant industry experience or comparable degree
Good communication in English (oral and written)
Ideally experience in the area of Pharmaceutical and Regulatory Affairs.
Quality and compliance conscious
Participating and supporting as necessary in audits/inspections
Ability to quickly familiarize with new IT tools.
Good expertise in organization and prioritization of tasks.
Ability to communicate and operate effectively in an international and cross-functional environment.
Problem solution oriented
Team spirit and embracing diversity of cultures and personalities.
Ability to work independently, under pressure, demonstrating initiative and flexibility
You’ll receive:
We offer temporary employment for 1 year with probation period with flexible working, learning and development opportunities. We offer indefinite employment contract based on performance after the first year of employment.
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
Skills Desired
Documentation Management, Operational Excellence, Regulatory ComplianceSkills Required
- University or college degree in any field or life science, with relevant industry experience or a comparable degree
- Good oral and written English communication skills
- Experience in pharmaceutical and regulatory affairs
- Quality and compliance awareness
- Ability to participate in and support audits or inspections
- Ability to quickly learn and use new IT tools
- Strong organization and task-prioritization skills
- Ability to communicate and work effectively in an international, cross-functional environment
- Problem-solving orientation
- Ability to work independently under pressure with initiative and flexibility
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.
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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.
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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.
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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.
Sandoz Insights
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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