Vice President, Regulatory Affairs Strategy- Oncology & Hematology

Society for Conservation Biology; Village of Tarrytown (NY); On-site; USD 300,000 - 500,000; Full time

Job summary

Join a forward-thinking company that leads in Oncology and Hematology drug development. This strategic role involves guiding regulatory affairs, ensuring compliance, and driving decision-making for product candidates. You'll leverage your extensive experience to foster collaboration across functions while influencing senior management on critical regulatory strategies. With a focus on innovation and problem-solving, you'll help shape the future of healthcare. If you're ready to make a significant impact in a dynamic environment, this is the opportunity for you!

Benefits

Health Programs

Fitness Centers

Equity Awards

Bonuses

Paid Time Off

Qualifications

• 15+ years of experience in the pharmaceutical industry, with 5+ years in regulatory roles.
• Experience in research labs or biotech product development is highly desirable.

Responsibilities

• Drive regulatory strategies for Oncology & Hematology product candidates.
• Oversee planning and submission of regulatory documentation.
• Serve as the regulatory expert for oncology and hematology.

Skills

Regulatory Strategy

Oncology Expertise

Hematology Expertise

Communication Skills

Team Leadership

Collaborative Problem-Solving

Education

Advanced Degree in Scientific Discipline

Job description

The role leads a group within Regeneron’s Regulatory Affairs organization that provides guidance to Research, Regeneron Genetics Center, Regeneron Cellular Medicine, and the Oncology and Hematology Clinical Development Units on regulatory strategies for developing Oncology & Malignant Hematology drug products. The position ensures all corporate objectives are met within timelines and maintains compliance. It also acts as a trusted advisor to senior management on regulatory strategies and processes, developing organizational objectives and understanding the impact of decisions across functions.

As a strategic leader, the incumbent will play a key role in the evolution of Regeneron’s Oncology & Hematology development candidates by leveraging cross-functional relationships. Additionally, they will lead the strategic development of a highly effective department to meet current and future demands.

A typical day might include...

• Driving decision-making on regulatory strategies for Oncology & Malignant Hematology product candidates to secure regulatory approvals within specified timelines.
• Designing regulatory communication strategies and ensuring alignment for projects and agency interactions.
• Leading the accuracy and completeness of information in regulatory submissions.
• Overseeing planning, preparation, and submission of regulatory documentation.
• Participating actively in Protocol Review and Development Program Review Committees.
• Managing regulatory liaisons and guiding project teams on submission content, format, and timing.
• Evaluating applications for regulatory compliance, clarity, and completeness.
• Serving as the oncology and hematology regulatory expert and proposing innovative solutions to complex regulatory issues.
• Maintaining good relationships with regulatory reviewers at FDA, EMA, and other authorities.

This role might be for you if...

• You hold an advanced degree in a relevant scientific discipline or have equivalent practical experience, especially in Oncology & Hematology.
• You possess at least 15 years of pharmaceutical or related industry experience, including 5+ years in regulatory roles.
• Experience in research laboratories, process development, or manufacturing of biotech products is highly desirable.
• You are business-oriented, with experience working closely with commercial and development teams.
• You have successfully developed and implemented functional strategies.
• You have led other development professionals in a scientific environment.
• You are an excellent communicator, capable of influencing and listening effectively.
• You foster a collaborative, innovative, and problem-solving culture and develop high-performing teams.

Does this sound like you? Apply now to begin your journey with Regeneron! We support an inclusive, diverse culture with benefits like health programs, fitness centers, equity awards, bonuses, and paid time off, depending on location.

Regeneron is an equal opportunity employer. All qualified applicants will receive consideration regardless of race, color, religion, sex, nationality, ethnicity, civil status, age, citizenship, membership in protected classes, sexual orientation, disability, genetic information, familial or marital status, pregnancy, gender identity, military service, or other protected characteristics. Reasonable accommodations are provided for known disabilities or chronic illnesses unless undue hardship occurs.

For U.S.-based roles, salary ranges are provided in accordance with U.S. law. For Japan and Canada, salaries are in local currencies and laws. Candidates outside these regions should consult with their recruiter regarding salaries and benefits.

Background checks are part of the recruitment process, conducted per local laws, to verify identity, work rights, education, and other credentials.

Salary Range (annually): $300,000.00 - $500,000.00