The responsibility of Senior Manager is to participate in the development and implementation of regional and global regulatory strategies for assigned development programs to support the pipeline growth in Jazz.

The other key responsibility includes planning, coordinating and compilation of complex regulatory submissions to obtain timely regulatory approvals, e.g., INDs, supplements to NDA and new therapeutic indications, PIPs, Orphans and will also represent RA on multidisciplinary sub-teams.

Essential Functions/Responsibilities

• Act as the Regional Regulatory Lead (RRL) in US, EU, Japan, and other regions for assigned projects.
• In collaboration with Global Regulatory Lead (GRL), develop regional regulatory strategy for assigned projects.
• Ensure projects are appropriately prioritized and progressed in accordance with agreed regulatory plans, with any identified risks (from emerging data, changing internal objectives or external threats) communicated to RA Senior Management in a timely manner
• Manage the preparation and timely submission of technically complex regulatory submissions e.g., INDs, NDA supplements, MAA, complex variations, new indications, PIP, Orphans, with minimal supervision, for assigned products in line with the regional regulatory requirements.
• Provide appropriate strategic regulatory input to Submission and Project Teams in a timely manner
• Lead regulatory interactions with the health authorities, external partners, and vendors for assigned products/projects
• Work with cross-functional matrix teams to gain alignment in line with corporate and departmental goals and objectives.
• Maintain knowledge of regulatory requirements and assess and communicate changes in regulatory information to project teams in a timely manner
• Lead local and/or global company process improvement initiatives
• Ensure all work is compliant with regulatory requirements and company policies and procedures

Required Knowledge, Skills, and Abilities

• Experience in core regulatory environment.
• Leading direct interactions with a variety of stakeholders including FDA, EMA, PMDA, and other Health Authorities pertaining to regulatory issues.
• Experience of leading complex regulatory submissions such as INDs, NDA supplements, MAA, and new indications.
• In-depth knowledge of regulatory landscape, including ICH and regional requirements for assigned territories and current regulatory trends
• Recognized as a knowledgeable resource for regulatory advice in other departments
• Good interpersonal skills and ability to deal effectively with a variety of personalities
• Excellent communication skills, strong oral/written presentation skills.
• Fluent written and spoken English
• Acts to promote an energizing, inclusive environment and good morale
• Ability to navigate and be successful in a fast-paced environment while delivering high quality results
• Adaptable to changing plans when situations require it and able to maintain composure and make decisions in uncertain circumstances
• Able to work independently with minimal supervision

Required/Preferred Education and Licenses

• BA/BS in scientific discipline required
• MS/PharmD preferred