Director, Regulatory Affairs

Davita Inc.; Princeton (NJ); On-site; USD 176,000 - 328,000; Full time

Job summary

Sandoz is seeking an experienced professional for a position focused on regulatory affairs at its Princeton, NJ headquarters. The ideal candidate will possess a Master's or PhD along with extensive experience in the pharmaceutical industry, specifically in regulatory strategies and approvals. This role supports Sandoz's commitment to delivering high-quality medicines and involves collaboration across various departments to ensure successful regulatory activities.

Benefits

Paid time off

401(k) plan

Health insurance

Flexible hybrid working policy

Qualifications

• 15+ years of pharmaceutical and/or biotech development experience.
• 10+ years of regulatory affairs strategy experience.
• Track record of successful regulatory development and product registrations.

Responsibilities

• Formulate regulatory strategies and communicate across functions.
• Develop and maintain relationships with development teams.
• Report project milestones and present project needs.

Skills

Regulatory strategy

Analytical thinking

Conflict resolution

Communication

Education

Masters degree or PhD

Job description

parental leave, paid time off, sick time, 401(k), remote work

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally.

Join us, the future is ours to shape!

Position Location:

This position will be located at the Princeton, NJ US Headquarters site.

Our Sandoz flexible hybrid working approach allows US office-based employees to work up to 50% of their monthly workday remotely. This role will not have the ability to be located remotely. Preference will be given to local candidates not requiring relocation.

Major Accountabilities / Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Formulate defensible regulatory strategies and recommendations on complex issues according to relevant laws, regulations and guidance documents.
• Creatively think "outside the box" on regulatory strategies and effectively communicate strategies across functions and business units.
• Use internal and external networks to ensure regulatory strategies are robust and keep pace with dynamic regulatory environment.
• Develop and maintain constructive and supporting working relationships with Sandoz Portfolio, Launch Management, Policy, and development teams.
• Communicate regulatory and development requirements to Global stakeholders.
• Partner closely across RA disciplines to ensure timely support of regulatory activities/filings, and lead in these areas where needed.
• Work with Policy team and provide input as needed on initiatives to support better working relationships with the FDA.
• Interface with senior Regulatory management, Sandoz Global Development Leadership and US Leadership as needed to report out project and program milestones, as well as present project needs.

What you'll bring to the role:

Required Qualifications:

Education:

• Masters degree or PhD.

Experience:

• 15+ years of pharmaceutical and/or biotech development related experience
• 10+ years of regulatory affairs strategy experience.
• Demonstrated track record of successful regulatory development, approval and maintenance of product registrations for complex drug products, including successful management of FDA meeting management and negotiations.

Preferred Requirements:

• Masters degree or PhD. in a scientific discipline.

You'll Receive:

Sandoz offers a generous employee benefits package that includes a competitive salary, health insurance coverage for medical, prescription drugs, dental and vision, a generous company match for retirement savings accounts, and generous paid time off. We also follow a hybrid work policy that combines a mix of in-person and remote work to allow our employees flexibility.

The pay range for this position at commencement of employment is expected to be between $176,400 - 252,000 - 327,600 USD/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, 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.

On September 30, 2021, Sandoz entered into a 5-year Corporate Integrity Agreement. Certain positions will have responsibilities to support the execution and adherence to CIA obligations, CIA-related deliverables, and any relevant audit, monitoring or Independent Review Organization (IRO) remediation.

Sandoz - Notice at Collection to Employees Applicants 4.15.24[16].pdf

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Sandoz, Inc. is 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 to perform the essential functions of a position, please send an email to [e-mail] or call 1-609-422-4098 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool (novartis.com)