AD Regulatory Affairs

Job Description

2015 was the year that Sandoz got approval for the first biosimilar in the United States. Over 20 years of experience in biosimilar development have equipped us with extensive knowledge and world-class expertise and capabilities in the development, manufacturing and commercialization of biosimilar medicines to the healthcare community and patients worldwide. This opportunity is waiting for you to contribute to Sandoz success story in the area of biosimilar toward the future, at the same time it becomes also the right step up in your career!
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.
• Provide regulatory and strategic leadership to assigned biosimilar/biotech project
• Represent RA on a Global Program Team (GPT)
• Lead a 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
• Identify, review and prepare high-quality RA documentation and correspondence during development, registration and maintenance phase, to obtain rapid and advantageous approvals worldwide, while respecting agreed strategies and e-publishing requirements, besides assuring congruency and compliance
The pay range for this position at commencement of employment is expected to be between $158,400 and $237,600 year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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.

Minimum Requirements

Requirements
• BS or 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
• 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

Why Sandoz?
500 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.
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!