Sandoz Hiring RA Associate Submission Management

Sandoz is a global leader in generic and biosimilar medicines, which are more affordable versions of brand-name drugs. The Swiss-based company was part of Novartis until October 2023 when it became an independent entity, and its products reach millions of patients worldwide. Sandoz also provides active pharmaceutical ingredients and has a portfolio of approximately 1,300 products, including over-the-counter medications and treatments for a wide range of conditions from cancer to the common cold.

Post : RA Associate - Submission Management

Job Description
• 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

Candidate Profile
• 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).

Additional Information
Job ID : REQ-10032877
Location : India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Submission Management
End Date : 30th November 2026