Regulatory Affairs Senior Manager

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Regulatory Affairs Senior Manager

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Geron Corporation
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Regulatory Affairs Senior Manager

role at

Geron Corporation
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Position Summary

The Regulatory Affairs Senior Manager provides regional (EU and other ex-US countries) support for all regulatory activities related to the ongoing development and life-cycle management of imetelstat (Rytelo) and future development product candidates. The Senior Manager holds supportive responsibilities in the areas of regulatory strategy, systems, processes, submissions, health authority interactions, and product labeling.
Position Summary

The Regulatory Affairs Senior Manager provides regional (EU and other ex-US countries) support for all regulatory activities related to the ongoing development and life-cycle management of imetelstat (Rytelo) and future development product candidates. The Senior Manager holds supportive responsibilities in the areas of regulatory strategy, systems, processes, submissions, health authority interactions, and product labeling.

The Senior Manager will interact closely with corresponding functional team members within the Company and will report directly to the Senior Director (EU Regulatory Lead), Regulatory Affairs.

This position is remote and will be based in the United Kingdom.

Primary Responsibilities

Submissions

Responsible for the preparation of post-approval centralized submissions and CTA packages in line with regulatory requirements
Works with Regulatory Affairs team members and functional subject matter experts to build and maintain the content plan for post-approval submissions, CTAs, etc. to ensure timely delivery of submission components
Works with EU Lead and project teams to develop regional submission plans and timing
Responsible for the preparation and/or review of documents for submission to regional regulatory agencies
Oversees management of responses to questions from regulatory agencies in a timely manner and in line with the product strategy
Contributes to the management of product life-cycle submissions (e.g., PSURs, DSURs, IB)
Works effectively with vendors to successfully execute above activities
Ensures that appropriate, up-to-date records are maintained for compliance

Regional Regulatory Strategy Implementation

Uses deep understanding of regional and local requirements to advise the EU Lead on implementation issues pertaining to regional regulatory strategies
Responsible for the implementation of the regional regulatory strategy, including the regulatory submission plans in line with agreed business objectives
Facilitates tactical implementation at the regional level and contributes to effective communications with the regional and global teams on product activities and issues
Keeps abreast of changing regulatory landscape to deliver knowledge management to the organization and contributes to a strong knowledge management base
Supports additional regulatory projects (e.g., conducting due diligence, supporting regulatory new initiatives) as needed

Regulatory Systems and processes

Assists in development of regulatory standards and SOPs
Undertakes necessary training and works effectively within internal regulatory document management systems and processes (Veeva RIM)

Health Authority Interactions

Participates in the preparation for meetings with regional regulatory agencies.(e.g. EMA and/or national agencies in the EU or other ex-US countries)
Manages communications with health authorities in support of submissions and other communications in association with Senior Director, Global Regulatory Affairs (EU Lead)

Labelling

Provides input into the development of regional product labelling as needed

Regulatory Input

Engages with Regulatory Affairs colleagues and representatives from other development functions to enable execution of regional strategies as appropriate

Competencies

Strong working knowledge of regulations and guidelines related to EU post-approval submissions as well as clinical trial submission and life-cycle management
Understanding of the impact of laws, regulations, guidance, rulings, and precedents on drug development
Demonstrated project management skills required, including the ability to handle multiple projects
Excellent verbal and written communication skills
Ability to work and thrive in a multi-cultural environment
Able to work flexible hours to accommodate meetings/teleconferences with different time zones
Must be available for periodic face-to-face meetings in the UK and occasional travel to the US

Experience

A minimum of Bachelor’s degree (or equivalent) in a scientific discipline required, advanced degree (MS, PhD, MD or PharmD) highly desired.
5-7 years of relevant regulatory experience with a bachelor's degree; 3-5 years with an advanced degree
Broad regulatory experience in EU geographic region preferred (experience across all phases of development) with prior global regulatory exposure/experience.
Experience with the centralized procedure and EU CTR is desirable
Experience working on/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.
Seniority level

Seniority level Mid-Senior level
Employment type

Employment type Full-time
Job function

Job function Legal
Industries Pharmaceutical Manufacturing
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