Execute a wide range of regulatory submissions independently
Manage a wide variety of global submissions, such as clinical study reports (CSRs), investigator’s brochures, DSURs
Represent RSM in cross-functional teams, providing guidance for optimal strategies
Plan and oversee assigned submissions with responsibilities including development and management of global and regional content plans
Act as a Subject Matter Expert for various expertise related to RSM Core Capabilities
Support regulatory maintenance activities for early development and late-stage products
Organize preparation of high-quality documents for internal stakeholders
Participate in development/improvement of submission standards, submission templates, and validation decision trees
Act as the primary interface with the publishing team to plan and negotiate publishing timelines and deliverables

6+ Years with BS/BA OR 4+ Years with MS/MA
BA/BS with 6+ relevant submission management, regulatory project management or regulatory operations experience in the biopharma industry
Significant experience in the biopharma industry is strongly preferred
Experience managing a broad range of submission types across multiple stages of drug development
Demonstrated ability to be a fast learner
Demonstrated ability to be flexible and adaptable to change
Recognized as a SME in a broad range of regulatory submission types
In-depth knowledge of relevant health authorities, including system, processes and regulatory requirements
Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, Smartsheet and Sharepoint as evidenced through accomplishments in past roles
Ability to lead and influence submissions, projects and/or initiatives
Strong interpersonal skills and understanding of team dynamics
Proven ability to work successfully in a team-oriented, highly matrixed environment

company-sponsored medical, dental, vision, and life insurance plans
discretionary annual bonus
discretionary stock-based long-term incentives (eligibility may vary based on role)
paid time off

Manager, Regulatory Submission Management

Key skills