2015 was the year that Sandoz got approval for the first biosimilar in the United States! Over 20 years of experience in biosimilar development and 8 biosimilars licensed globally have equipped us with extensive knowledge and capabilities in the development, manufacturing and commercialization of biosimilars to increase access to life-saving medicines to patients worldwide. This opportunity is waiting for you to contribute to Sandoz’ success story in the future and at the same time it becomes also the right step up in your career.
Prepares and submits regulatory filing documents. Monitors and tracks information and requirement changes. Some interaction with regulatory agencies required.
Your Responsibilities include, but are not limited to:
• Independently reviews and compiles ANDAs, Amendments, Supplements, Annual Reports, etc. for FDA submissions in eCTD format as per FDA
regulations and guidelines.
• Reviews Labeling Change Control requests and approves revised labeling documents, which may include physician and patient package inserts as well as various types of container labels.
• Interacts effectively with functional business units in order to obtain documentation required for submissions
• Evaluates, reviews, and processes change controls to communicate regulatory submission strategies and acquire necessary and compliant documentation.
• Frequent interaction with Regulatory Agencies.
• Maintains compliance with regulatory requirements for generic drugs for the US market.
• Maintains Regulatory Databases.
*Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to Princeton, NJ for periodic live meetings will be at the employee’s expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager.
Diversity & Inclusion / EEO
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. 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.
What you'll bring to the role:
• Bachelor’s Degree in a scientific related field, preferred, with 1-3 yrs regulatory experience. Associate’s Degree is accepted with minimum 5 years regulatory experience.
• Good Problem solving skills
• Strong working knowledge of regulatory and drug development processes
• Adherence to all health, safety & environmental requirements in support of departmental and site HSE goals. Work in a safe and efficient manner.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Sandoz!
Commitment to Diversity & Inclusion:
Novartis 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 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
Accessibility and reasonable accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.