As posted by the hiring company
Job Description500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
The Associate Director Global Regulatory Affairs is responsible for regulatory and strategic leadership to assigned biosimilar/biotech projects. You will also be responsible to prepare, compile high quality documentation for complex global regulatory submissions in various countries.
For our team in Princeton we are looking for a
Associate Director Global Regulatory Affairs (d/f/m)
• Provide regulatory and strategic leadership to assigned biosimilar/biotech project
• Represent RA on a Global Program Teams (GPT) or closely work with Global RA GPT representative
• Lead and/or be key member of the Global Regulatory (sub)team. Provide strategic input to GPT and GRS / RA team and on key HA documents
• Liaison with Regulatory Authorities in US and globally.
• Effectively address regulatory issues that may surface during regulatory reviews and prepare and facilitate preparation of responses to Authorities in various countries worldwide
• Responsible for development and implementation of the Regulatory Strategy and Risk Documents
• Ensure appropriate line function endorsement
• Provide regulatory and strategic input on:
• development concepts and documents (e.g. dev plan, CTA/IND, briefing books, dossier documents)
• clinical study protocols and protocol amendments
“This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require X% travel.”
Minimum requirementsWhat you’ll bring to the role:
• MS with requisite experience and demonstrated capability
• Advanced degree (MD, PhD, PharmD) preferred
• At least 5 years of relevant regulatory and drug/biologic development experience preferred
• Good understanding of regulatory requirements for drug development, clinical studies, dossier filings worldwide and critical evaluation of emerging requirements, guidelines for new drugs and product life cycle maintenance
• Strong ability to construct persuasive scientific/regulatory documents. Strong ability to interpret scientific and commercial information
• Proven experience in HA negotiations in different regions
• Proven project leadership skills and experience in leading in matrix environment
• Proven ability to work in a complex and international setting
• Strong interpersonal skills, team player
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!
EEO StatementThe 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.