Senior Director, Regulatory & Scientific Affairs

The Senior Director, Regulatory & Scientific Affairs, is responsible for developing and executing global regulatory strategies to support the advancement of clinical development programs from early development through registration and lifecycle management.

Requirements

• Advanced degree in life sciences or clinical discipline
• Minimum 10 years of regulatory affairs and/or clinical development experience in CRO, biotech, or pharmaceutical environments
• Demonstrated experience serving as a regulatory strategy lead across multiple programs
• Experience advising sponsors and supporting complex regulatory strategy
• In-depth experience in communication with clients and internal teams
• Experience providing expert knowledge of the drug and/or device development process and associated regulatory requirements
• Experience providing advanced technical skills in Microsoft Office including Word, PowerPoint, Excel, and ability to quickly learn and adapt to new systems and technologies
• Experience in preparation of technically complex documents intended for submission to regulatory authorities (e.g., briefing documents, clinical study reports)
• Demonstrated history of direct interaction with regulatory agencies (e.g., FDA, EMA, Health Canada)
• Proven expertise as a Clinical or Regulatory lead managing drug and/or device development projects pre- and post-marketing
• Experience providing Expert knowledge of ICH Good Clinical Practice guidelines and applicable regulatory requirements
• Experience mentoring or developing regulatory professionals

Benefits

• Generous health benefits
• Vacation packages
• Hybrid work from home opportunities
• Paid parental leave