RA Associate

IN04 (FCRS = IN004) Sandoz Private Limited; Telangana; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Sandoz Private Limited, part of the global Biosimilar and Generic medicines group, seeks a regulatory/documentation professional in Telangana to manage controlled documentation, ensure regulatory compliance, and support data analysis for dossiers and product information. The role emphasizes adherence to regulatory standards and timely handling of documentation changes.

The position focuses on maintaining records, coordinating submission components, and ensuring consistency across documentation

Qualifications

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

Responsibilities

• 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).

Skills

Data Analysis

Documentation Management

Operational Excellence

Job description

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! 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).

Minimum Requirements

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

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.

Skills Desired

Data Analysis, Documentation Management, Operational Excellence

Our Purpose

here at Sandoz is pioneering access for patients. As the global leader in 'off-patent' high quality medicines, we are able to make medicine more affordable and accessible. Our broad global portfolio comprises of approximately 1,300 quality biosimilar and generic medicines, enabling us to provide more than 900 million patient treatments across 100+ countries per year, and while we are proud of this achievement, we have an ambition to do more! Powered by our talented and ambitious colleagues, who, in return for dedication and skills, experience a flexible, collaborative & inclusive culture where diversity of thought is welcomed and where personal growth is nurtured!