Regulatory Affairs Strategist for Oncology Innovation
2 weeks ago
About Daiichi Sankyo
Daiichi Sankyo Group is a pharmaceutical leader dedicated to creating innovative therapies that improve patient outcomes. With over 100 years of experience, our global presence spans more than 20 countries.
Our vision for 2025 is to become a "Global Pharma Innovator with Competitive Advantage in Oncology." We focus on developing novel treatments for cancer and other rare diseases. As a key player in the industry, we strive to leverage our scientific expertise to deliver meaningful treatments for patients.
Key Responsibilities
- Develop and implement US regulatory strategies for assigned projects, ensuring timely and efficient development plans.
- Serve as the primary point of contact with FDA, coordinating meetings, and negotiating agreements.
- Lead preparation of FDA submissions, including briefing documents, breakthrough therapy designation requests, and orphan drug applications.
- Participate in global project team meetings, providing regulatory support and guidance.
- Review and interpret regulatory guidelines to ensure compliance.
Required Skills and Qualifications
- Bachelor's Degree required; Advanced degree preferred.
- At least 10 years of experience in the pharmaceutical industry, with 8+ years in regulatory affairs.
- Proven ability to interpret US regulations governing the pharmaceutical industry.
- Excellent communication and interpersonal skills, with the ability to work in a team environment.
Benefits and Compensation
- Estimated salary: $120,000 - $160,000 per year, depending on experience.
- A comprehensive benefits package, including health insurance, retirement plan, and paid time off.
- Opportunities for professional growth and development.
We are an Equal Opportunity Employer
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