Associate Director, Global Regulatory Strategy – Oncology

BioSpace; Cambridge (MA); On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

Best-in-class healthcare coverage

Well-being resources

Generous paid time off

Job summary

A leading biotech company in Cambridge, MA, seeks an experienced Associate Director of Regulatory Strategy to lead oncology therapeutic programs. This role requires extensive experience in regulatory affairs, particularly in oncology, to ensure alignment between US and global strategies. Exceptional communication skills and leadership are essential for successful FDA interactions and regulatory submissions. The role offers robust healthcare benefits and a positive workplace environment.

Qualifications

• 7+ years of experience in the pharmaceutical industry preferred.
• 5+ years in regulatory strategy or relevant training/experience preferred.
• Strong knowledge of current US regulations.

Responsibilities

• Serve as the global regulatory lead delegate for oncology programs.
• Set strategic direction for the US market in collaboration with teams.
• Lead the strategy for US FDA interactions and submissions.

Skills

Leadership

Communication skills

Organizational skills

Regulatory knowledge

Oncology therapeutics experience

Education

BA/BS in a scientific/engineering/healthcare discipline

Masters, PharmD or PhD preferred

Job description

A leading biotech company in Cambridge, MA, seeks an experienced Associate Director of Regulatory Strategy to lead oncology therapeutic programs. This role requires extensive experience in regulatory affairs, particularly in oncology, to ensure alignment between US and global strategies. Exceptional communication skills and leadership are essential for successful FDA interactions and regulatory submissions. The role offers robust healthcare benefits and a positive workplace environment.