DRC Specialist

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.

Your Responsibilities:
Your responsibilities include but not are limited to:

•Authoring/responsible for preparation of regulatory submissions (e.g. ANDS, ANDA, SANDS) with support and guidance, applying agreed global regulatory strategies, assuring technical congruency, and regulatory compliance, meeting agreed upon timelines and requirements throughout project life cycle.
•Prepare 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 to DRC manager for global regulatory strategy for developments projects with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance.
•Interact with cross-functional teams in SDC, India for assigned development projects and prepare timely query responses, as appropriate. Assume specialized assignments as assigned and represent own departments in cross-functional project teams.
•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

• Regulatory experience mandatory (minimum of 5 years), and/or experience in pharmaceutical industry in US, EU, Most of world market etc.
• Working knowledge of chemistry, analytics or pharmaceutical technology. Knowledge of the drug development of process desirable. Ability to critically evaluate data from a broad range of science disciplines.
• Solid knowledge of ICH, EMA, US FDA guidelines and regulatory procedures.
• Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
• Effective planning, organizational and interpersonal skills.
• Excellent written/spoken communication and negotiation 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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