Manager, Regulatory Affairs Biopharma
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 Talent Acquisition & Staffing – EVP 2019 Business Use Only 18 future, at the same time it becomes also the right step up in your career within clinical development!
The Manager of Regulatory Affairs Biopharma is an exciting opportunity to join Sandoz biosimiliars; an important area of drug development bringing patients and prescribers affordable medicines. The individual will have the opportunity to be the direct contact at the FDA. Manage multiple products across different therapeutic areas. Be a contributor of regulatory strategies in drug development in all phases of development, including post-approval and life-cycle management. The individual will work closely with the global Biopharm Regulatory Affairs (BRA) Leads to 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.
Your Key Responsibilities:
• Understands US environment, and precedents: Provides input into global regulatory strategy, contributes to Regulatory Functional Plan (RFP) and Seed Document, and identifies gaps or risks
o Understand US legislation, regulatory policy and technical regulatory guidance relating to biosimilar products and understand the impact on current and future submissions
o Serve as local FDA liaison
o Represents US BRA as a member of the cross-functional project team to provide US regulatory guidance throughout development, launch and post-approval process
o Define strategies to mitigate risks.
• US Health Authority Interactions: Determines requirements and sets objectives. Insure briefing documents are clear and support teams objective
o Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects and programs, including IND, BLA, etc product line extension application, change control supplements and labeling supplements.
o Reviews summary with an eye for US perspective
o Set up rapid response team to answer US questions
o Reviews, approves and submits Investigational New Drugs (INDs).
o Ensures the overall regulatory strategy aligns with the target product profile
• Executes and manages operational activities for assigned projects
• Contributes to and leads development of departmental goals and objectives.
• Maintain compliance for assigned product
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 bring to the role:
• Bachelors Degree in a science area
• 5 years in regulatory or pharma exp
• Innovative Mindset and strong desire to be part of a growing team in regulatory supporting biosimilars
Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!
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.
Learn more here
Job posted: 2021-01-28