Head of Regulatory Affairs

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.
• Deep knowledge of FDA and Health Canada frameworks; cross-border submissions a plus.
• Experience with diverse modalities including small molecules, biologics and gene therapies.

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.
• Partner with cross-functional teams to support discovery, development, and manufacturing.
• Lead, mentor, and grow a small regulatory team.
• Present to and build relationships with internal and external stakeholders.

Skills

Regulatory strategy

FDA compliance

Leadership

Team mentoring

Knowledge of GMP

GMP/GLP/GCP

Cross-functional

Education

Advanced degree (MSc or PhD)

Job description

We are proud to partner with an innovative biotechnology company in the search for a Senior Director, Regulatory Affairs. This fully remote role (US or Canada) will lead regulatory strategy, execution, and compliance across discovery, development, and manufacturing, with a primary focus on early-stage, first-in-human / first-in-class molecules.

Key Responsibilities:

• Develop and oversee regulatory strategy across all phases of drug development.
• Provide leadership on early-stage regulatory submissions (INDs, CTAs, pre-INDs).
• Ensure compliance with FDA and Health Canada requirements, including CTA and IND processes.
• Partner with cross-functional teams to support discovery, development, and manufacturing programs.
• Lead, mentor, and grow a small regulatory team.
• Serve as a collaborative partner, presenting to and building relationships with internal and external stakeholders.

Required Qualifications:

• 10+ years of regulatory affairs experience within biotech, pharma, or CRO environments.
• Advanced degree (MSc or PhD) strongly preferred.
• Proven track record in regulatory strategy and submissions for early-stage programs in North America (FDA and Health Canada).
• Experience spanning diverse indications and modalities, including small molecules, biologics, and gene therapies.
• Prior leadership and mentoring experience, or demonstrated ability and desire to grow into a team leadership role.
• Deep understanding of FDA and Health Canada frameworks; global submission experience a plus.
• Strong knowledge of GMP, GLP, and GCP.
• Experience with the 505(b)(2) pathway is highly desirable.

Why Join?

This is a highly visible, collaborative leadership role in a forward-looking biotech company developing novel therapies. You will have the opportunity to shape regulatory strategy, mentor a growing team, and directly influence programs at the cutting edge of science.

If you meet the above criteria and are actively seeking your next regulatory leadership role, we encourage you to apply.

The company offers a competitive package, including medical insurance, vision insurance, and 401(k).