Regulatory Affairs Senior Manager

Position Summary

The Regulatory Affairs Senior Manager provides regional support for all regulatory activities related to the ongoing development, registration, and life-cycle management of imetelstat and potential future development product candidates. The Senior Manager holds supportive responsibilities, including in areas of regulatory strategy, systems, processes, submissions, health authority interactions, and product labeling.

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

Primary Responsibilities

• Advises on implementation issues pertaining to regulatory strategies based on thorough understanding of regional and local requirements
• Supports the implementation of the regional regulatory strategy, including submission plans in line with agreed upon business objectives
• Facilitates tactical implementation at the regional level and contributes to effective communication with the regional and global teams on product activities and issues
• Keeps abreast of changing regulatory landscape to deliver knowledge management to the organization
• Supports additional regulatory projects (e.g., conducting due diligence and supporting regulatory new initiatives) as needed
• Assists in development of regulatory standards, Company SOPs, and work instructions
• Likely to have specific responsibility for tasks and projects related to implementation, ongoing maintenance, and training of Veeva Vault and Starting Point templates
• Participates in the preparation for meetings with regional regulatory agencies
• Supports communications with FDA in support of submissions
• Responsible for the preparation and provides review and input on documents for submission to regional regulatory agencies
• Contributes to the preparation of registration dossiers (e.g., NDAs)
• Works with Regulatory Affairs team members and functional subject matter experts to build and maintain the content plan for INDs, NDAs, etc. to ensure timely delivery of submission components
• Works with project teams to develop regional marketing approval submission plans and timing
• Supports management of responses to questions from regional regulatory agencies in a timely manner and in line with the product strategy
• Maintains current IND submissions by ensuring timely and appropriate submission of required information within eCTD sequence
• Contributes to the management of product lifecycle submissions (e.g., DSURs)
• Work effectively with all vendors to successfully execute above activities
• Ensures that appropriate, up-to-date records are maintained for compliance
• Engages Head of Regulatory, ex-US regulatory colleagues, and representatives from other development functions to enable execution of regional strategies as appropriate
• May have oversight of external regulatory contractors/consultants

Competencies

• In-depth knowledge and high level of technical competence of regulatory systems (e.g., Veeva Vault and Starting Point templates); ability to advise and train end-users as appropriate
• Good working knowledge of regulations and guidelines related to drug development and registration; understanding of the impact of laws, regulations, guidance, rulings, and precedents on drug development; knowledge management skills and experience is desirable
• Demonstrated ability to handle multiple projects
• Excellent English verbal and written communication skills
• Ability to work and thrive in a multi-cultural environment
• Must be able to work flexible hours to accommodate early morning/late evening meetings/teleconferences within different time zones

Experience

• Bachelor's degree (or equivalent) in a scientific discipline is required; advanced degree (MS, PhD, MD, or PharmD) is highly desired
• 5-7 years of relevant regulatory experience with a bachelor's degree; 3-5 years with an advanced degree
• Global regulatory affairs experience in drug development and commercialized products is required
• Regulatory experience in North American geographic region preferred, with prior global regulatory exposure/experience
• Experience in working with and leading project teams
• Demonstrated contributions to drug development projects and implementation of strategies is desirable

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 to $155,000