Associate Director, Regulatory Affairs

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
• Strong 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
• Proficient in MS Office suite
• Travel %: 20%

To apply, click here.