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:

• To set registration plan, to perform product registration in accordance with registration
and launch plan, & maintain product license with local regulation and global compliance strategy. Review new projects and set development plan (timeline etc.) in collaboration with Global
• DRA and related CPO functions (Marketing, HE&P and CD&MA etc.)
• Achieve the best product registration with commercially attractive labelling in accordance with registration plan
• Maintain and secure product license in terms of CMC/CDS/safety update according to local regulations/law/guidelines, company strategy and global compliance
• Perform IND application & get aproval to ensurestudy timeline in collaboration with medical team and Global DRA
• Ensure compliance with NP4, KRPIA code of conduct, relevant regulations and laws for related CPO activities (DRAGON update, RMP, packing materials, promotional materials/activities, PMS/drug safety reporting etc.)
• Foster and maintain good relations with internal and external stakeholders. Reporting of technical complaints / adverse events / special case scenarios related to 1/3 Novartis products within 24 hours of receipt
• Distribution of marketing samples (where applicable)

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

Able to understand changing dynamics of Pharmaceutical industry
Cross Cultural Experience
Experience working cross-functionally and trans-nationally
Functional Breadth
Operations Management and Execution
Project Management
Regulatory Submissions
Strong negotiation and analytical skills
Working experience within the pharmaceutical industry

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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