We are proud to partner with an innovative biotechnology company in the search for aSenior 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).
