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.
An exciting opportunity to be a Regulatory lead at Sandoz in biosimilars; an important area of drug development bringing patients and prescribers affordable medicines. The individual will have the opportunity to be the direct contact with the FDA. Manage multiple products across different therapeutic areas. Experience drug development across all at all phases of development, early development, post-approval and life cycle management. An important component of the work is to develop US regulatory strategies and understand precedents leading to strong global filings. The individual will work closely with the global Biopharm Regulatory Affairs individuals. Provide critical US perspective for regulatory strategies (precedents), provide regulatory guidance, critically review documents for submission to FDA, and oversee the execution of the US regulatory strategy in line with the project team’s goals. Represent US BRA on cross-functional project teams, commercial teams, and provide strategic regulatory leadership.
Your Responsibilities Include but are not limited to:
• Acts as a FDA liaison contact for project issues.
• Represents US regulatory affairs as a member of the cross-functional project team to provide US regulatory guidance throughout launch and post-approval process.
- Understand US legislation, regulatory policy and technical regulatory guidance relating to biosimilar products and understand the impact on current and future submissions
- Ensures the overall regulatory strategy aligns with US country specific needs, US biosimilar regulatory environment, and global development strategy for assigned projects
- Responsible for implementing regulatory strategy and operational activities
- Identifies and assesses regulatory risks associated with product development. Defines strategies to mitigate risks
- Reviews reports from contributing functions and provides comments to assure accurate and complete documents for FDA submissions
• Maintain compliance for assigned products: Acts as a single point of contact for the business for US regulatory issues on assigned projects
• Interacts with key personnel (scientific, clinical, and commercial) within Sandoz and external partners to ensure timely, high quality submission that meet the needs of the US biosimilar regulations and marketing launch
• Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects and programs, including IND, sBLA, product line extension application, change control supplements and labeling supplements
• Works with US organization
- Member of commercial team: understand differentiation strategy and communicate this back into global registration and LCM strategy
- Medical affairs
- Various US specific needs including NDC, country or origin, environmental analysis, Human factor protocol, REMS, etc.
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:
Science degree required; advanced degree preferred
• Minimum 7 years regulatory experience.
• Strong knowledge of regulatory biologic submission and approval process
• Experience leading regulatory submissions and approvals
• Experience in global matrix environment and cross functional teams
• Proven ability to analyze and interpret efficacy, safety, and CMC data
• Regulatory operational experience
• Strong interpersonal, communication, and problem-solving skills
• Organizational awareness (interdepartmental and business priorities)
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
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.
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.