RA Senior Associate - Submission Management

Sandoz India; Telangana; Presencial; INR 600.000 - 1.000.000; Jornada completa

Descripción de la vacante

Sandoz India is seeking a Regulatory Affairs professional to support Module 1 submissions and lifecycle management. You will coordinate regional documentation, ensure compliance, and maintain document metadata and version control across systems.

The role requires experience with regulatory processes, strong attention to detail, and proficiency in Excel. Collaboration with QA, Pharmacovigilance, Manufacturing, RA, Legal, and country teams is essential for timely submissions.

Formación

• Relevant experience in pharmaceutical regulatory affairs, with module 1 lifecycle management.
• Organized, detail-oriented, quality-focused with data integrity commitment.
• Strong Excel and MS Office skills; structured data handling.
• Good English communication, team collaboration in a global environment.

Responsabilidades

• Support preparation, compilation, review, and maintenance of Module 1 documentation.
• Prepare and maintain regional administrative documents and submission checklists.
• Coordinate collection of signatures, approvals, and documentation for regional submissions.
• Maintain Module 1 document lifecycle in electronic document management systems.
• Support updates to regional administrative requirements and digital tools.
• Demonstrate willingness to learn regulatory procedures and work with assigned markets.

Conocimientos

Regulatory affairs

Module 1 experience

Attention to detail

Excel

English communication

Herramientas

eCTD/NEES

Descripción del empleo

• 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 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.

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 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.

What you bring?

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.

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