Regulatory Affairs Operations Senior Manager

Geron; California, Foster City (MO, CA); Remote; USD 80,000 - 120,000; Full time

Job summary

An innovative firm is seeking a Regulatory Affairs Operations Senior Manager to lead the end-to-end submissions process. This remote position offers the opportunity to implement new technologies and improve processes within regulatory operations. You will work independently, ensuring compliance with agency guidelines while managing records and training end-users. The ideal candidate will have a strong background in regulatory submissions, excellent communication skills, and the ability to adapt to changing priorities. Join a forward-thinking company where your expertise will significantly impact the biopharmaceutical landscape.

Qualifications

• 5-7 years of regulatory operations experience in biopharmaceuticals.
• Advanced knowledge of agency guidelines (ICH, FDA, EMA).

Responsibilities

• Manage the end-to-end submissions process and maintain product data.
• Audit submissions for compliance and support end-users with tools.

Skills

Regulatory Submissions

Document Management

Communication Skills

Project Management

Attention to Detail

Education

Bachelor's Degree in a Scientific Discipline

Tools

Veeva RIM

EDMS

MS Office

StartingPoint

Job description

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 maintaining product data within the company's Regulatory Information Management (RIM) system. The role supports the implementation of new technology, tools, and processes, and identifies opportunities for continuous improvement.

This position is remote with headquarters in Foster City, CA, and Parsippany, NJ. The Senior Manager reports to the Director of Regulatory Affairs.

Primary Responsibilities

1. Utilize electronic document management system (EDMS) and publishing tools to assemble and publish NDA/MAA/IND submissions, ensuring compliance with regulatory requirements and working independently.
2. Audit published submissions for conformance and coordinate content review.
3. Maintain submission content plans and monitor adherence to timelines.
4. Dispatch submissions via agency portals (e.g., FDA ESG, EMA eSubmission Gateway).
5. Assist with Clinical Trial Application (CTA) submissions under EU Clinical Trial Regulations.
6. Manage records within the company's RIM system (Veeva RIM).
7. Create and manage reports from RIM to support daily activities.
8. Archive submissions and correspondence in RIM.
9. Support end-users through training and troubleshooting of EDMS/RIM tools.
10. Format regulatory documents per style guides and agency requirements.
11. Interact with agency portals as needed.
12. Provide guidance on technical submission requirements.
13. Monitor business trends, regulations, and emerging technologies impacting regulatory operations.
14. Develop action plans, country requirement guides, and business tools accordingly.

Competencies

• Advanced knowledge of agency guidelines (e.g., ICH, FDA, EMA).
• Proficiency in formatting and publishing regulatory documents using applicable software (e.g., StartingPoint).
• Guidance on formatting, publishing, and archiving regulatory documents.
• Ability to work independently with minimal supervision.
• Strong communication skills.
• Ability to multitask, pay attention to detail, and see projects through.
• Highly organized and adaptable to changing priorities and deadlines.

Experience

• Bachelor's degree in a scientific discipline.
• 5-7 years of regulatory operations experience in biopharmaceuticals, focusing on submissions or RIM data management.
• Experience with MS Office, EDMS, Veeva RIM, and document templates (e.g., StartingPoint).
• Experience with agency portals (e.g., FDA ESG, EMA eSubmission Gateway, Eudravigilance, IRIS, CTIS).
• Project management experience in cross-functional teams.