DRC Associate

Job Description

1886! We have more than 130 years of experience treating patients.
Sandoz, a division of Novartis, is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide.

The role of DRC Manager, Development Regulatory Center (DRC) is to ensure: Regulatory filings/dossiers are prepared and support DRC Manager as per established development milestones. Take project ownership within DRC for projects with lower degree of complexity and supports DRC Manager for high complex projects. Timely regulatory approval is obtained by relevant Health Authorities.
• Support DRC in preparation of regulatory submissions (e.g. ANDS, ANDA, SANDS) as well as query responses to health authority questions during development and registration in close collaboration with relevant SDC departments.
• Identify the required documentation for global submissions and communicate expected delivery dates of technical source documents in accordance with project timelines given by project management and SDC departments.
• Identify and escalate as appropriate content, quality and/or issues with source documents, or any other potential authorizing issues that may impact submission quality or timelines, as early as possible. Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
• Active participation as a member of development team by contributing to the regulatory strategy, identifying critical issues and applying lessons learned.
• Establish and maintain sound working relationship with all Sandoz Regulatory affairs departments and as well SDC teams.
• Support DRC manager/specialist for global regulatory strategy for developments projects with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance.
• Assume specialized assignments as assigned and represent own department in cross-functional project teams. Other tasks as assigned by the supervisor and tasks based on a specific appointment. Other tasks determined during the annual objectives setting process and by KPIs.
• Implementation of and compliance with all the instructions and requirements for safety at work, environment protection, and property protection.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

•3-5 years of Experience
•Cross Cultural Experience
•Functional Breadth
•Operations Management
•ExecutionProject Management
• Effective planning, organizational and interpersonal skills.

Why consider Sandoz?
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?

The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.

Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

Imagine what you could do at Sandoz!

Commitment to Diversity & Inclusion:

Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Group Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

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