Executive Director, Regulatory Affairs — Late-Stage Oncology

Trebla Talent; Boston (MA); Remote; USD 160,000 - 230,000; Full time

Job summary

Trebla Talent is seeking an Executive Director of Regulatory Affairs for a clinical-stage biotechnology company in Boston, Massachusetts. This role provides strategic regulatory leadership primarily for late-stage development programs, including oncology initiatives. The successful candidate will guide global regulatory strategies and collaborate across various departments.

Qualified individuals should possess over 15 years of relevant experience and a strong background in regulatory submissions. Remote candidates in the eastern timezone will also be considered.

Qualifications

• 15+ years of Regulatory Affairs experience within the biotechnology or pharmaceutical industry.
• Significant experience in global regulatory strategy for late-stage oncology programs.
• Demonstrated success leading NDA and/or BLA submissions.

Responsibilities

• Lead global regulatory strategy for late-stage development programs.
• Drive regulatory strategy for NDA and/or BLA submissions.
• Mentor and influence colleagues while fostering a collaborative culture.

Skills

Regulatory Affairs

NDA/BLA submissions

Communication skills

Scientific acumen

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Job description

Trebla Talent is seeking an Executive Director of Regulatory Affairs for a clinical-stage biotechnology company in Boston, Massachusetts. This role provides strategic regulatory leadership primarily for late-stage development programs, including oncology initiatives. The successful candidate will guide global regulatory strategies and collaborate across various departments.

Qualified individuals should possess over 15 years of relevant experience and a strong background in regulatory submissions. Remote candidates in the eastern timezone will also be considered.