Associate Director, Regulatory Affairs Project Management
Scorpion Therapeutics, New Bremen, OH, United States
Role Summary
Associate Director, Regulatory Affairs Project Management on the Regulatory Affairs team to help expand what’s possible for patients with serious diseases. Reporting to the Director, Regulatory Affairs Project Management, you’ll work with global submission teams to plan and manage complex regulatory submissions (including global marketing applications, product line extensions, and supplements) from submission preparation to approval, ensuring that dossiers are prepared in a timely manner and in compliance with Regulatory Authority regulations and Insmed Operating Procedures. This is a fully remote role with occasional travel for team meetings or events.
Responsibilities
In collaboration with contributing functional lines, create and maintain a Global Submission Plan that captures detailed list of dossier content, key activities and timelines associated with delivery of the submission and associated anticipated approval dates
Work with Regulatory team to coordinate post initial submission activities in support of approval process, such as FDA Advisory Committee meetings, mock rehearsals, Oral Explanation meetings etc.
Utilize in-depth knowledge of global regulatory submission requirements, processes and procedures, eCTD structure/format, associated Insmed systems and planning software to ensure teams meet aggressive target submission dates by proactively focusing on critical path analysis, hand offs, scenarios, and reducing "rework" to avoid costly time delays
Coordinate submission documents/components for simultaneous global regulatory submission projects in eCTD format (e.g., NDA/BLA/INDs, MAAs, JNDAs, etc.)
Track timely delivery of submission components, including internal review and approvals and coordinate submission publishing activities with the publishing team
Understand, adhere to, and advise others on global Regulatory Authority regulations and guidance associated with electronic submissions, which differ across regions and Regulatory Authorities
Possess proven project management, organizational and time management skills to manage multiple ongoing projects simultaneously
Qualifications
Project management experience in the pharmaceutical industry or in a regulatory environment, with expertise in Smartsheet and/or other project management tools
Regulatory experience from pre-IND through Phases I–IV for FDA, EMA, MHRA and PMDA
Excellent written and verbal communication skills and ability to present information in a clear and concise manner
Excellent organizational skills, attention to detail and commitment to deliver high quality output
Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams
Software requirements: Veeva Vault RIM, Smartsheet, Microsoft Office
Skills
Regulatory planning and submission management
Cross-functional collaboration and stakeholder management
Knowledge of global regulatory submission requirements (including eCTD)
Strong analytical and problem-solving abilities
Education
Bachelor’s Degree (in life sciences or chemistry preferred)
Additional Requirements
Travel: Minimal travel required (occasional travel for team meetings or events may be expected)
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Responsibilities
In collaboration with contributing functional lines, create and maintain a Global Submission Plan that captures detailed list of dossier content, key activities and timelines associated with delivery of the submission and associated anticipated approval dates
Work with Regulatory team to coordinate post initial submission activities in support of approval process, such as FDA Advisory Committee meetings, mock rehearsals, Oral Explanation meetings etc.
Utilize in-depth knowledge of global regulatory submission requirements, processes and procedures, eCTD structure/format, associated Insmed systems and planning software to ensure teams meet aggressive target submission dates by proactively focusing on critical path analysis, hand offs, scenarios, and reducing "rework" to avoid costly time delays
Coordinate submission documents/components for simultaneous global regulatory submission projects in eCTD format (e.g., NDA/BLA/INDs, MAAs, JNDAs, etc.)
Track timely delivery of submission components, including internal review and approvals and coordinate submission publishing activities with the publishing team
Understand, adhere to, and advise others on global Regulatory Authority regulations and guidance associated with electronic submissions, which differ across regions and Regulatory Authorities
Possess proven project management, organizational and time management skills to manage multiple ongoing projects simultaneously
Qualifications
Project management experience in the pharmaceutical industry or in a regulatory environment, with expertise in Smartsheet and/or other project management tools
Regulatory experience from pre-IND through Phases I–IV for FDA, EMA, MHRA and PMDA
Excellent written and verbal communication skills and ability to present information in a clear and concise manner
Excellent organizational skills, attention to detail and commitment to deliver high quality output
Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams
Software requirements: Veeva Vault RIM, Smartsheet, Microsoft Office
Skills
Regulatory planning and submission management
Cross-functional collaboration and stakeholder management
Knowledge of global regulatory submission requirements (including eCTD)
Strong analytical and problem-solving abilities
Education
Bachelor’s Degree (in life sciences or chemistry preferred)
Additional Requirements
Travel: Minimal travel required (occasional travel for team meetings or events may be expected)
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