Global Regulatory Strategy Leader, Oncology

Verastem Oncology; Boston (MA); On-site; USD 220,000 - 290,000; Full time

Benefits offered by this job

Annual bonus

Equity compensation

Competitive benefits package

Job summary

Verastem Oncology is looking for a Senior Director of Regulatory Affairs based in Boston, MA. This role involves leading the development and implementation of the global regulatory strategy for investigational products, ensuring alignment with U.S. regulations and international guidelines. You will maintain documentation, represent the company in meetings with regulatory authorities, and guide other departments in application submissions.

The ideal candidate will have an advanced scientific degree and significant experience in regulatory affairs, with a deep understanding of U.S. regulations. The position offers a competitive salary ranging from $220K to $290K, along with bonuses and benefits.

Qualifications

• 8+ years of experience in regulatory affairs or drug development for advanced degrees.
• 10+ years of industry experience for Bachelor's degrees.
• Direct experience in clinical regulatory sciences.

Responsibilities

• Develop and implement global regulatory strategies for products.
• Represent Verastem in meetings with regulatory authorities.
• Guide teams on INDs, CTAs and NDAs/BLAs requirements.
• Monitor global regulations and competitive developments.

Skills

Leadership

Effective communication

Regulatory knowledge

Clinical regulatory sciences

Conflict management

Education

Advanced scientific degree (PhD, PharmD, MS)

Bachelor’s degree

Job description

Verastem Oncology is looking for a Senior Director of Regulatory Affairs based in Boston, MA. This role involves leading the development and implementation of the global regulatory strategy for investigational products, ensuring alignment with U.S. regulations and international guidelines. You will maintain documentation, represent the company in meetings with regulatory authorities, and guide other departments in application submissions.

The ideal candidate will have an advanced scientific degree and significant experience in regulatory affairs, with a deep understanding of U.S. regulations. The position offers a competitive salary ranging from $220K to $290K, along with bonuses and benefits.