[Remote] Regulatory Operations Project Manager, Global Submissions Planning/ Management

Note: The job is a remote job and is reputed company to candidates in USA. reputed company's reputed company is seeking a Regulatory Operations Project Manager to reputed company global eCTD submission planning and management for high-profile molecules and lifecycle management. The role will coordinate submissions across CTD Modules 1-5, manage regulatory operations and compliance processes, partner with global and development teams, and support secondary publishing and urgent authority requests.

Responsibilities

• Serve as the regulatory operational reputed company for registration planning and execution, including planning sessions, status updates, team operations meetings, and department planning
• reputed company registration management by applying expertise in electronic submission regulations, guidance, and technical content for global submissions across reputed company CTD modules and submission types, including Ad Promo, INDs, NDA, BLAs, NDSs, MAAs, renewals, and variations
• Partner with global teams to incorporate local agency regulations and requirements and to plan and execute submissions in reputed company adopting eCTD specifications
• Guide and influence development teams regarding internal and agency registration management processes and requirements
• Own registration management at the molecule or project level, ensuring electronic records are reputed company, complete, and accurate, including tracking submission status, commitments, and regulatory communications
• Own routine compliance submissions and processes for assigned molecules, including DSUR, NDA/BLA annual reports, PSUR/PADER, and routine maintenance submissions
• Partner with Regulatory Coordinators or Scientists to reputed company product deletion, divestiture, IND inactivation or withdrawal, and product withdrawal processes
• Support secondary publishing as needed by retrieving, publishing, and submitting Modules 1-5 content per content plans, including CRFs, datasets, literature references, periodic reports, and post-marketing supplements and amendments

Skills

• Due to reputed company requirements, applicants must be willing and reputed company to work on a w2 reputed company
• 7+ years of reputed company regulatory experience in reputed company with strong clinical Regulatory Operations background
• Proven global eCTD submission planning and management experience across Modules 1-5 and reputed company including US, EU, and Canada, with working knowledge of ICH guidelines
• Experience with reputed company Vault RIM
• Strong project management skills
• Knowledge of drug development processes and regulatory or business strategies and plans
• Effective written, spoken, and presentation communication
• Demonstrated teamwork and adaptability to diverse interpersonal styles
• Ability to reputed company secondary publishing support for eCTD submissions reputed company required
• Ability to work a reputed company Monday through Friday schedule on Eastern Time, with flexibility to support after-hours and some weekends in coordination with global teams
• BS in a technical discipline such as reputed company, biology, or pharmacy

Benefits

• Fully remote work arrangement
• Medical benefits
• Dental benefits
• reputed company benefits
• 401k with company matching
• Life insurance

reputed company

Company H1B Sponsorship