Associate Director, Regulatory Affairs - Remote

Overview

The Associate Director, Regulatory Affairs will be a key player in shaping regulatory strategies for oncology products at Deciphera, a biopharmaceutical company focused on cancer treatments.

In Short

• Join a team of regulatory professionals in the biopharmaceutical sector.
• Shape regulatory strategies across the product pipeline.
• Provide regulatory support for oncology products from development to post-approval.
• Oversee the filing of INDs, CTAs, and marketing applications.
• Monitor global regulatory changes affecting asset development.
• Ensure compliance with regulatory strategies and submissions.
• Collaborate with cross-functional teams and senior management.
• Utilize advanced knowledge of oncology drug regulations.
• Engage with regulatory bodies like the FDA.
• Support a mission to improve the lives of people with cancer.

Requirements

• B.S/M.S. with 10+ years in pharmaceutical regulatory affairs.
• 5+ years of experience with global development and submission plans.
• Advanced knowledge of regulations related to oncology drug development.
• Experience with INDs and NDAs.
• Ability to provide regulatory solutions and guidance.
• Strong communication skills for cross-functional collaboration.
• Proactive monitoring of regulatory changes.
• Commitment to compliance and quality.
• Experience engaging with FDA and other regulatory bodies.
• Ability to adapt to a fast-paced environment.

Benefits

• Competitive salary and annual bonus.
• Comprehensive benefits package including health insurance and 401(k).
• Generous parental leave and family planning benefits.
• Opportunities for personal and professional growth.
• Supportive and inclusive company culture.