Are you looking for an impactful career in the heart of the pharmaceutical industry? Sandoz, a globally recognized leader in sustainable biosimilar and generic medicines, is on an exciting journey of transformation. As we navigate through this ambitious path, we offer unique professional and personal opportunities for innovative individuals. If you’re passionate about healthcare and regulatory affairs, consider applying for the DRC Specialist position at our Telangana office.
About Sandoz
Sandoz, a division of Novartis, is committed to providing high-quality access to medicines for patients around the world. With a portfolio that includes over 1000 generic and biosimilar medicines, Sandoz has helped treat more than 900 million patients in over 100 countries in 2024 alone. Our mission is to continue breaking barriers in the healthcare industry, and we are dedicated to innovation, customer collaborations, and sustainable practices.
Job Description
Key Responsibilities
As a DRC Specialist, your role will involve:
- Regulatory Strategy Implementation: Design and manage regulatory activities for assigned regions, supporting both operational and global objectives.
- Stakeholder Collaboration: Work with regional teams to align on regulatory strategies, ensuring business goals are effectively met.
- Health Authority Interactions: Prepare and manage interactions with Health Authorities (HA), including developing briefing books and summary documents.
- Dossier Submission Coordination: Drive the planning and submission of regulatory dossiers, while working to avoid delays during review processes.
- Clinical Trial Applications Management: Review and submit Clinical Trial Applications (CTAs) and Investigational New Drug (IND) applications.
- Risk Management: Lead negotiations for regional approvals and facilitate compliance with regulatory standards.
Essential Requirements
To be successful in this role, you should have:
- A minimum of 5+ years in Regulatory Affairs.
- Proven ability to produce high-quality project documentation; no delays due to insufficient evaluation and submission errors.
- Strong communication and collaboration skills, ensuring timely and accurate information flow among stakeholders.
- High-quality strategic evaluation and regulatory compliance skills.
Benefits of Working at Sandoz
At Sandoz, we believe that our employees are our most valuable asset. Here’s what you can expect:
- Flexible Working Arrangements: A work-life balance that meets your personal and professional needs.
- Learning and Development Opportunities: Continuous improvement and growth in your career, with access to training and professional courses.
- An Inclusive Work Environment: Collaborate with diverse teams, embracing different perspectives to drive innovation.
How to Apply
