Remote Regulatory Affairs Director - Global Submissions

Satellos; Markham; Hybrid; CAD 110,000 - 160,000; Full time

Job summary

Satellos Bioscience Inc. seeks an Associate Director, Regulatory Affairs to drive global regulatory activities across our DMD and FSHD programs.

You will lead regulatory strategy, interactions with authorities, and cross-functional alignment to advance programs toward potential FDA approvals. Reporting to the Chief Development Officer and Head of Regulatory Affairs, you will influence development plans, ensure compliance, and mentor teams in a fast-paced start-up setting.

Qualifications

• 7–10 years in the pharmaceutical/biotech industry with at least 5 in Regulatory Affairs.
• Experience with global regulatory pathways (EMA, Health Canada, PMDA, etc.).
• Experience leading major global submissions (NDA/BLA/MAA).
• Ability to draft regulatory strategy from development through lifecycle management.

Responsibilities

• Prepare and submit regulatory dossiers including INDs, CTAs and amendments.
• Provide regulatory input to clinical development plans and study documents.
• Review and approve promotional, clinical and safety materials for regulatory compliance.
• Maintain regulatory intelligence and communicate impacts to programs.
• Lead regulatory interactions with Health Authorities (pre-IND/CTA meetings, etc.).
• Maintain relationships with agencies, CROs, CDMOs and other partners.
• Develop and review regulatory SOPs aligned with GxPs and industry standards.
• Participate in study team meetings and address regulatory questions.
• Identify opportunities and risks within Regulatory department and programs.

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

eCTD expertise

Regulatory intelligence

Problem solving

Attention to detail

Regulatory risk management

Education

Bachelor’s degree in a scientific discipline

MS/PhD preferred

Tools

eCTD submission tools

Regulatory submissions tracking systems

Job description

Satellos Bioscience Inc. seeks an Associate Director, Regulatory Affairs to drive global regulatory activities across our DMD and FSHD programs.

You will lead regulatory strategy, interactions with authorities, and cross-functional alignment to advance programs toward potential FDA approvals. Reporting to the Chief Development Officer and Head of Regulatory Affairs, you will influence development plans, ensure compliance, and mentor teams in a fast-paced start-up setting.