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Job Details


Novartis

Associate Director, Regulatory Strategy and Science RA Biopharma

Pharmaceuticals

All

Yearly

No

Princeton, New Jersey, United States

Job Description 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.