Regulatory Affairs Operations Senior Manager

Position Summary

The Regulatory Affairs Operations Senior Manager is responsible for the accurate and efficient execution of the Company’s end-to-end submissions process as well as the maintenance of product data within the Company’s Regulatory Information Management (RIM) system. The Senior Manager also supports the implementation of new technology, tools, and processes and helps identify opportunities for continuous improvement.

This position is remote with a corporate headquarters in Foster City, CA and Parsippany, NJ. The Senior Manager will report to the Director, Regulatory Affairs.

Primary Responsibilities 

• Utilize electronic document management system (EDMS) and publishing tools to assemble and publish NDA/MAA/IND submissions of varying complexity, according to regulatory requirements, with a high degree of independence
• Audit published submissions for conformance with published technical requirements and coordinate the submission content review   
• Assist with maintaining the content plan for submissions and follow up with deliverable owners to maintain adherence with timelines
• Dispatch submission via agency portals (e.g., FDA ESG or EMA eSubmission Gateway)
• May assist with Clinical Trial Application (CTA) submissions covered by EU Clinical Trial Regulations (CTR)
• Manage records such as product, applications, submissions, commitments, etc. within the Company’s RIM system (Veeva RIM)
• Build and manage reports from the RIM system to support users with their day-to-day activities and support processes 
• Archive submissions and correspondence within the RIM system
• Support end-users of the EDMS/RIM system via training on tool functionalities or troubleshooting of reported issues with the tool
• Format regulatory submission documents according to internal style guide and agency requirements
• Interact with agency portals (e.g., FDA Direct, Eudravigilance (for xEVMPD), IRIS, Product Lifecycle Management (PLM) portal, Clinical Trial Information System (CTIS), etc.), as needed
• Provide input and guidance on current technical submission requirements
• Monitor and assess business trends, pending regulations or guidance documents, and emerging technologies for potential regulatory operations impact
• Assist in developing action plans, country requirement guides, and business tools accordingly

Competencies 

• Advanced knowledge of agency (e.g. ICH, FDA, EMA) guidelines related to submissions and product data
• Advanced skills for formatting and publishing regulatory documents using applicable software tools/templates (e.g., StartingPoint)
• Ability to provide guidance on formatting, publishing, and archiving regulatory documents
• Ability to work independently with minimal supervision
• Strong verbal and written communication skills
• Ability to multi-task, pay close attention to detail, and follow projects through to completion
• Highly organized and able to adapt to changing priorities and deadlines

Experience

• Bachelor's degree in scientific discipline
• 5-7 years of regulatory operations experience in the biopharmaceutical industry, either focused on publishing of NDA/MAA/IND submissions or maintenance of data in RIM systems, or a combination of both
• Experience with MS Office applications, EDMS, Veeva RIM, and document authoring templates (e.g., StartingPoint)
• Experience with using agency portals (e.g., FDA ESG, EMA eSubmission Gateway, FDA Direct, Eudravigilance (xEVMPD), IRIS, PLM Portal, CTIS, etc.)
• Demonstrated project management experience working in cross-functional team environment to develop, implement, and deliver on project goals

The information below is exclusively for candidates based in the United Kingdom

All regular-status, full-time employees of Geron UK Limited are eligible to participate in the Company’s comprehensive benefit program, pursuant to plan terms and conditions.  Plan choices include private medical, dental, life assurance, disability insurance, workplace pension, and travel insurance.  Geron also provides regular-status, full-time employees with a generous time off program that includes 160 hours of vacation and 80 hours of sick time in addition to normal UK public holidays.   

The information below is exclusively for candidates based in the United States

EEO Statement: 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. 

Benefit Statement:

All regular-status, full-time employees of Geron are eligible to participate in the Company’s comprehensive benefit program, pursuant to plan terms and conditions.  Plan choices include medical, dental, vision, life insurance, flexible spending accounts, disability insurance, supplemental health insurance, a 401(k) retirement savings plan, and an employee stock purchase plan.  Geron also provides regular-status, full-time employees with a generous time off program that includes the eligibility to accrue 160 hours of vacation during each full year of employment, 64 hours of sick leave, 9 standard paid holiday days off, and paid leave for certain life events.  Geron recognizes that its employees work in many different states and therefore may be affected by different laws.  It is Geron’s intention to comply with all applicable federal, state, and local laws that apply to the Company’s employees.

Salary Statement:

Offered compensation is determined based on market data, internal equity, and an applicant’s relevant skills, experience, and educational background.  The salary ranges displayed below are only for those who, if selected for the role, will perform work in the specific locations listed.  Please note the employment opportunity is not limited to these locations. 

General Salary Range: $135,000 - $150,000