Location

Remote / Flexible (Eastern time strongly preferred)

Reports to

Chief Development Officer and Head of Regulatory Affairs

POSITION SUMMARY The Associate Director, Regulatory Affairs will support global regulatory activities for Satellos’ pipeline, including our programs in DMD and FSHD.

Reporting to the Chief Development Officer and Head of Regulatory Affairs, he/she will play a critical role in advancing Satellos’ pipeline, including our lead program in DMD to a potential FDA approval in 2027.

KEY RESPONSIBILITIES

Collaborate with cross-functional teams to prepare, coordinate and submit regulatory dossiers including INDs, global CTAs, amendments, annual reports, safety updates and responses to information requests

Provide regulatory input to clinical development plans, protocols, informed consent forms, and investigator brochures

Review and approve promotional, clinical and safety materials for regulatory compliance

Maintain regulatory intelligence on guidance, policy changes, and competitor activity; assess impact on programs

Lead or contribute to regulatory interactions with Health Authorities (pre-IND/CTA meetings, end-of-phase, scientific advice) including drafting meeting requests, Q&A;’s, briefing documents and meeting minutes

Maintain strong relationships and communication with external stakeholders, including regulatory agencies, CROs, CDMOs, consulting groups, and other third parties

Lead development and review of regulatory SOPs and work instructions aligned with GxPs, Guidance, industry standards, and corporate objectives

Participate in study team meetings, providing updates and addressing questions as necessary





Proactively identify opportunities and risks within our Regulatory department and the development programs, and support approaches to mitigate and resolve risks

QUALIFICATIONS

Bachelor’s Degree in a relevant scientific discipline; advanced degree preferred (MS, PharmD, or PhD)

7 to 10 years of experience in the pharmaceutical or biotechnology industry; at least 5 of those years in Regulatory Affairs

Experience with global regulatory pathways (EMA, PMDA, Health Canada, etc.) and harmonization initiatives (ICH guidelines);

Experience with rare disease pathways preferred

Experience leading at least one major global submission (NDA/BLA/MAA/PMA)

Demonstrated experience serving as the Regulatory Affairs lead for development programs, providing regulatory strategy from early development through registration and lifecycle management

Hands on experience with eCTD assembly, submission tracking and publishing tools

Ability to serve as the Regulatory Affairs subject matter expert and collaborate effectively with cross-functional teams and senior leadership on regulatory risk, strategy, and development decisions

Ability to independently assess complex regulatory issues and recommend risk-based solutions in a dynamic start-up environment

Exceptional planning and execution skills

Robust analytical and decision-making skills with attention to detail and quality

Ability to anticipate and solve problems

Ability to adapt and succeed in a milestone-driven, start-up

Satellos does not accept unsolicited resumes from agencies or search firms. Recruiters are requested not to contact employees or hiring managers. All candidate submissions must be coordinated through our Human Resources team and require a prior written agreement. Any resumes sent without such an agreement will not create any implied obligation.

📌 Associate Director, Regulatory Affairs (Winnipeg)
🏢 Satellos
📍 Winnipeg