RA Associate - Submission Management

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!

The Region Europe Regulatory team (RER) is responsible for management of all drug regulatory affairs matter in region Europe and its countries and acts as an interface between the business development licensing/development/maintenance regulatory centers, country organizations and EU authorities.

The RER EU team is responsible to obtain marketing authorizations for EU, Great Britain and Switzerland, as defined in an agreed registration strategy, and make sure the product is ready for launch from a regulatory perspective.

The RER EU team is responsible to obtain marketing authorizations for EU, Great Britain and Switzerland, as defined in an agreed registration strategy, and make sure the product is ready for launch from a regulatory perspective.

Job Description

Major accountabilities: 

Support preparation, compilation, review, and maintenance of Module 1 documentation for Variations, Renewals, Responses to Health Authority queries, PSUR/PSUSA support activities, Low-complexity new submissions with input and oversight for RER, RGD, RGD-IL, RGLC, RBLC, RGLB, RGL, 2nd wave submission RER manager.

Prepare and maintain regional administrative documents including Application forms, Cover letters, Certificates, Other legal and administrative documentation. Support completeness, consistency, and compliance checks of Module 1 packages against regional requirements, internal standards, submission checklists, and strategic plans.

Coordinate timely collection of signatures, approvals, authorizations, and supporting documentation from relevant functions (e.g., QA, Pharmacovigilance, Manufacturing, RA, Legal, Country teams). Support submission publishing readiness by ensuring correct document metadata, naming conventions, formatting, and version control for Module 1 documents prepared and stored in the company electronic document management systems.

Maintain lifecycle of Module 1 documents in relevant electronic document management systems as required. Support preparation of country-specific administrative responses and clarification packages during validation and review, with input and oversight for RER, RGD, RGD-IL, RGLC, RBLC, RGLB, RGL, 2nd wave submission RER manager.

Support implementation of updates to regional administrative requirements, templates, and checklists as communicated by Senior Associate, Specialists, Senior Specialists, or Managers. Participate in process improvement initiatives, standardization efforts, and implementation of digital tools.

As necessary, input and maintain Regulatory Information for assigned products in relevant electronic information management systems. Demonstrates willingness to learn regulatory procedures and develop expertise within assigned markets and processes.

Decision Making - Works independently on assigned maintenance activities, escalates complex regulatory issues to manager or senior specialist or specialist, and follows established procedures and regulatory guidance.

Scope & Complexity - Responsible for routine and low complex maintenance submission activities. Supports low-complexity new marketing authorization applications and works within established processes and standard operating procedures.

 Education / Language / Experience: 

Relevant experience in pharmaceutical, healthcare, regulatory affairs, regulatory submission management. Prior experience working with module 1, lifecycle management.

Basic knowledge of Regulatory Affairs processes. Organized, Curious, Strong attention to detail, Quality focused, committed to compliance and data integrity.

Good Excel and Microsoft Office skills, ability to work with structured data.

Strong Team spirit and the ability to work collaboratively in a global team environment. Familiarity with eCTD/NeeS concepts and regional administrative requirements for at least one market/region preferred.

Languages: Good communication in English (oral and written).

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

Data Analysis, Documentation Management, Operational Excellence