Sandoz Hiring DRC Associate

Sandoz Hiring: Join the Team as DRC Associate

Are you ready to be part of an exciting journey with Sandoz? In 2023, Sandoz is set to become an independent organization, paving the way for new opportunities and growth. As a global leader in Generics and Biosimilar medicine, this is a unique chance to make a lasting impact both professionally and personally.

Job Purpose:

As a DRC (Development, Regulatory, and Commercialization) Associate at Sandoz, you will play a crucial role in providing operational and regulatory support to Novartis, as well as regional and global organizations. Your responsibilities will encompass preparing and submitting regulatory dossiers, maintaining databases and archives, and handling artwork-related activities.

Key Responsibilities:

Coordinate and prepare high-quality submissions of regulatory dossiers for assigned products.
Achieve targeted dates for CTA/NDA submissions and approvals.
Ensure timely license renewal submissions and approvals.
Manage CMC/BPI/PSUR/RMP in compliance with regulations.
Assist in coordinating discussions with regulatory authorities.
Keep track of registration status and update line managers.
Maintain good communication and relationships with stakeholders.
Adhere to company and department SOPs and procedures.
Report technical complaints, adverse events, and special cases related to Novartis products.
Distribute marketing samples (where applicable).

Commitment to Diversity & Inclusion:

At Novartis, we are committed to building an inclusive work environment that represents the patients and communities we serve.

Minimum Requirements:

What You’ll Bring to the Role:

At least 3+ years of experience in the US/Europe/Canada market, preferred.
Hands-on experience in pre-approval stages.
Experience with solid dosage forms.

Why Sandoz?

Sandoz impacted the lives of 500 million patients with generic and biosimilar medicines in 2021. But we believe there’s more we can do to pioneer access to medicines worldwide. We’re driven by the intersection of medical science and digital innovation, and we embrace diversity, equity, and inclusivity to inspire new ways of working.

Commitment to Diversity & Inclusion:

We are committed to building a diverse team that represents the patients and communities we serve.

Join the Sandoz Network:

Even if this role isn’t the perfect fit for you, you can stay connected and learn more about Sandoz and our career opportunities by joining the Sandoz Talentpool at Sandoz Talentpool (novartis.com)

Division: Sandoz

Business Unit: Small Molecules STO

Work Location: Hyderabad, AP

Company/Legal Entity: Sdz Pvt Ind

Functional Area: Research & Development