JOB SUMMARY:

Responsible for drafting cover letters for submissions and for being the regulatory point of contact internally for DSURs and IBs and for other documents as needed. Supports the implementation of regulatory strategies for product development and commercialization in emerging disease areas.

This role will collaborate with internal CMC, Clinical Dev, Clin Ops, Safety, Quality departments to manage regulatory submission deliverables, including any activities as determined by the Project Regulatory Lead in support of the creation and execution of Regulatory Development plans and timelines.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Foster strong relationships with team members and functional line managers, supporting project-related communications and issue identification and management
• Support internal decision-making processes and preparing regular updates for senior management and program teams
• Supports regulatory submissions and timelines, including queries to regulatory authorities and Health Authority meeting requests
  • Activities include: scheduling meetings, planning agendas, preparing minutes, and following-up with team members on critical action items
  • Support the coordination of Health Authority meeting requests, meeting rehearsals, briefing book preparations, and preparing meeting minutes of meetings
• Executes, independently or with limited guidance, submissions to maintain regulatory applications, including routine amendments, DSURs, and IND safety reports
• Archives, maintains and tracks all submissions, queries US and ex US
• Maintaining up-to-date knowledge and expertise of FDA/EMA/Other relevant regulations/guidance documents, and ICH guidelines
• Other duties and projects as assigned

EDUCATION/KNOWLEDGE/SKILLS/ABILITIES REQUIRED:

• Bachelor’s degree in life sciences required. Advanced degree strongly preferred.
• 4-8 years of relevant experience in regulatory affairs; or equivalent combination of education and experience
• Broad understanding of international regulations and guidance
• Strong experience in IND and CTA filings. NDA/BLA/MAA filing experience preferred
• Excellent written and verbal communication skills
• Strong ability to prioritize workload
• Able to prospectively identify potential problems and to partner effectively and positively to solve issues