Associate Director, Regulatory Operations
Scorpion Therapeutics, New Bremen, Ohio, United States
Role Summary
The Associate Director, Regulatory Operations will be responsible for daily operational activities within Regulatory Affairs to ensure delivery of timely, accurate, and high-quality submissions to regulatory health authorities. Reporting to the Senior Director, Regulatory Operations, this role is also responsible for the implementation and management of regulatory systems and processes to ensure compliance. This is a remote role based in the US, with occasional travel.
Responsibilities
Responsible for forward planning of publishing resources; provide operational oversight of external publishing vendors for the coordination, delivery, and dispatching of regulatory submissions.
Maintain electronic regulatory systems necessary to carry out functional activities; work with solution providers to identify, validate, and implement system enhancements.
Train and support cross-functional contributors on the use of regulatory systems to support submission planning and execution.
Maintain accurate, accessible records of submission filings, health authority correspondences, and regulatory milestones.
Perform document formatting and publishing to generate submission-ready documents in accordance with regional specifications and requirements.
Work closely with the other members of the Regulatory Affairs team to provide submission and publishing strategy support as needed.
Lead the development and maintenance of SOPs and work instructions related to electronic submissions, records management, and regulatory systems.
Drive continued evolution of reporting and analytics capabilities using systems and tools to provide a robust view of regulatory activities.
Evaluate and communicate emerging technology changes and regulatory submission requirements to inform decision making and long-range planning.
Qualifications
Bachelor’s degree in a scientific or related field.
Minimum 8 years' experience in a biotech or pharmaceutical company with at least 5 years of experience in regulatory operations.
Hands-on experience formatting, publishing, compiling, and dispatching regulatory submissions in eCTD format.
Direct experience supporting or administering a validated, document management system (Veeva Vault RIM strongly preferred).
Highly proficient in MS Word document formatting with and without the use of third-party authoring templates.
Knowledge of global regulatory submission regulations and submission requirements.
Strong project management skills, detail oriented, and team-oriented leadership skills are essential.
Ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors.
Direct experience with compiling major submission applications (e.g., Original NDA/BLA/MAA) is preferred.
Experience managing external publishing vendors is preferred.
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Responsibilities
Responsible for forward planning of publishing resources; provide operational oversight of external publishing vendors for the coordination, delivery, and dispatching of regulatory submissions.
Maintain electronic regulatory systems necessary to carry out functional activities; work with solution providers to identify, validate, and implement system enhancements.
Train and support cross-functional contributors on the use of regulatory systems to support submission planning and execution.
Maintain accurate, accessible records of submission filings, health authority correspondences, and regulatory milestones.
Perform document formatting and publishing to generate submission-ready documents in accordance with regional specifications and requirements.
Work closely with the other members of the Regulatory Affairs team to provide submission and publishing strategy support as needed.
Lead the development and maintenance of SOPs and work instructions related to electronic submissions, records management, and regulatory systems.
Drive continued evolution of reporting and analytics capabilities using systems and tools to provide a robust view of regulatory activities.
Evaluate and communicate emerging technology changes and regulatory submission requirements to inform decision making and long-range planning.
Qualifications
Bachelor’s degree in a scientific or related field.
Minimum 8 years' experience in a biotech or pharmaceutical company with at least 5 years of experience in regulatory operations.
Hands-on experience formatting, publishing, compiling, and dispatching regulatory submissions in eCTD format.
Direct experience supporting or administering a validated, document management system (Veeva Vault RIM strongly preferred).
Highly proficient in MS Word document formatting with and without the use of third-party authoring templates.
Knowledge of global regulatory submission regulations and submission requirements.
Strong project management skills, detail oriented, and team-oriented leadership skills are essential.
Ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors.
Direct experience with compiling major submission applications (e.g., Original NDA/BLA/MAA) is preferred.
Experience managing external publishing vendors is preferred.
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