Remote Senior Director of Regulatory Strategy

RPM ReSearch; Boston (MA); On-site; USD 180,000 - 280,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A biotech company is seeking a Senior Director of Regulatory Affairs for a fully remote role. This position involves leading regulatory strategy and compliance for early-stage drug development. The ideal candidate will have over 10 years of experience in regulatory affairs and a strong background in submissions for North American markets. This role offers a competitive compensation package, including medical benefits and 401(k).

Qualifications

• 10+ years of regulatory affairs experience within biotech, pharma, or CRO environments.
• Proven track record in regulatory strategy and submissions for early-stage programs.
• Strong knowledge of GMP, GLP, and GCP.

Responsibilities

• Develop and oversee regulatory strategy across all phases of drug development.
• Provide leadership on early-stage regulatory submissions (INDs, CTAs, pre-INDs).
• Partner with cross-functional teams to support development programs.

Skills

Regulatory strategy

FDA compliance

Leadership

Team mentoring

Knowledge of GMP

Education

Advanced degree (MSc or PhD)

Job description

A biotech company is seeking a Senior Director of Regulatory Affairs for a fully remote role. This position involves leading regulatory strategy and compliance for early-stage drug development. The ideal candidate will have over 10 years of experience in regulatory affairs and a strong background in submissions for North American markets. This role offers a competitive compensation package, including medical benefits and 401(k).