Senior Manager, Global Submission Management - Americas

• Manage and mentor an impactful AIN team responsible for Regulatory submission management to Americas markets.
• Implement optimized resourcing strategies, demonstrating internal teams and external partners for submission-related activities in the AIN context.
• Drive process improvements for submission tools, methodologies, and workflows.
• Ensure staff understanding and adherence to global and regional regulatory guidelines.
• Help to ensure regulatory information and systems meet global compliance standards.
• Help to develop and implement policies, SOPs, training materials, and guidelines for regulatory practices.
• Champion innovation within submission processes to drive efficiency and maintain industry leadership.Required Knowledge and Skills:
• Proven leadership in regulatory submission management to the US and regional markets.
• Advanced knowledge of regional regulatory requirements for clinical trial applications, marketing authorisations and associated submissions, including eCTD and related software.
• Expertise in regulatory information management systems (RIMS) and publishing solutions.
• Strong project/program management skills and the ability to manage cross-functional teams.
• Effective collaboration and communication skills with internal/external stakeholders and regulatory authorities.
• Analytical and problem-solving skills to address complex regulatory and systems issues.What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of regulatory submissions or systems experience OR
• Masters degree and 8 to 10 years of regulatory submissions or systems experience OR
• Bachelors degree and 10 to 14 years of regulatory submissions or systems experience OR
• Diploma and 14 to 18 years of regulatory submissions or systems experience

Preferred Qualifications:

• Extensive leadership in submission management of eCTD in US, Canada and submissions across Central and South America.
• Advanced knowledge of global and regional regulatory requirements for submissions, including eCTD and related software.
• Advanced expertise in regulatory publishing systems.
• Strong project/program management skills and the ability to manage cross-functional teams.
• Effective collaboration and communication skills with internal/external collaborators and regulatory authorities.
• Analytical and problem-solving skills to address complex regulatory and systems issues.
• Experience with global regulatory submission delivery
• Experience with large-scale enterprise systems in the Biotech/Pharmaceutical industry.
• Experience in regulatory operations, submission management.