Manager, Regulatory Ops – Submission Management
Gilead Sciences
full-time
Posted on:
Location Type: Hybrid
Location: Cambridge • United Kingdom
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About the role
- Manages the submission execution activities for a wide variety of global submission projects, such as clinical study reports (CSRs), variations, investigator’s brochures, DSURs, regulatory responses, original INDs and amendments.
- May support regulatory portfolio planning activities or submission execution for multiple submissions of varying complexity including global marketing applications.
- Represents RSM in cross-functional teams, such as product, project and/or regulatory submissions teams; providing guidance for technical strategies to achieve fast frictionless filings or meet technical health authority requirements; may act as a technical and operational lead for submission execution.
- Plans and oversees assigned submissions with responsibilities including development and management of global and regional content plans and resource planning for assigned submissions.
- Supports the planning and preparation of maintenance activities for early development and late-stage regulatory deliverables with direction from RA Liaisons.
- Organizes preparation of high-quality documents for submissions such as cover letters, forms and other documents as assigned.
- Participates in development/improvement of submission standards, submission templates, and validation decision trees.
- May also participate in other special projects and/or represent RSM in other cross-functional initiatives.
Requirements
- BA/ BS with relevant submission management, or regulatory operations experience in the biopharma industry, or relevant experience with MA/MS/MBA, or relevant experience with PharmD/PhD.
- Significant experience in the biopharma industry is strongly preferred.
- Experience with content planning for a broad range of submission types across multiple stages of drug development utilizing Veeva
- Experience working with one or more Gilead TAs (Virology, Inflammation and Oncology) and varying stages of drug development is strongly preferred.
- In-depth knowledge of relevant health authorities, including system, processes and regulatory requirements.
- In-depth knowledge of regulatory document requirements and guidelines relevant to assigned products, projects, and markets.
- Knowledge of Veeva content planning and publishing best practices and tools with proven ability to apply these to improve submission efficiency and effectiveness.
- Proficient with Veeva, DocuBridge, Microsoft Office suite, Smartsheet and SharePoint.
Benefits
- Equal Employment Opportunity (EEO) policy
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
submission managementregulatory operationscontent planningdrug developmentregulatory document requirementssubmission standardssubmission templatesvalidation decision treesbiopharma industry experiencetechnical strategies
Soft Skills
organizational skillscommunication skillscross-functional teamworkguidanceplanningoversightleadership
Certifications
BABSMAMSMBAPharmDPhD