Associate Director, Regulatory Strategy and Science RA Biopharma


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Princeton, NJ

Job Description

As posted by the hiring company

Job Overview:

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. Leads FDA project meetings and major label negotiations with FDA.
• Represents US BRA as a member of the cross-functional project team to provide US regulatory guidance throughout development, 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
- Provides input into regulatory functional plan (RFP) strategy document
- 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, BLA, NDA, 510(k), 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.

Minimum requirements

What you'll bring to the role:

• Science degree required; advanced degree preferred
• Minimum 7 years regulatory experience.
• Strong knowledge of regulatory submission and approval process
• Experience leading regulatory submissions and approvals
• Experience in global matrix environment and cross functional teams
• Experience preparation of Briefing Books with global teams, FDA meeting preparations, rehearsals and HA negotiations
• 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)

Why Sandoz:

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.

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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.

Vaccine Policy:
While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected]

EEO Statement

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.