Regulatory Affairs Senior Manager

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Regulatory Affairs Senior Manager

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Geron CorporationJoin to apply for the

Regulatory Affairs Senior Manager

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Geron CorporationGet AI-powered advice on this job and more exclusive features.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 requirementsWorks 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 componentsWorks with EU Lead and project teams to develop regional submission plans and timingResponsible for the preparation and/or review of documents for submission to regional regulatory agenciesOversees management of responses to questions from regulatory agencies in a timely manner and in line with the product strategyContributes to the management of product life-cycle submissions (e.g., PSURs, DSURs, IB)Works effectively with vendors to successfully execute above activitiesEnsures 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 strategiesResponsible for the implementation of the regional regulatory strategy, including the regulatory submission plans in line with agreed business objectivesFacilitates tactical implementation at the regional level and contributes to effective communications with the regional and global teams on product activities and issuesKeeps abreast of changing regulatory landscape to deliver knowledge management to the organization and contributes to a strong knowledge management baseSupports 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 SOPsUndertakes 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 managementUnderstanding of the impact of laws, regulations, guidance, rulings, and precedents on drug developmentDemonstrated project management skills required, including the ability to handle multiple projectsExcellent verbal and written communication skillsAbility to work and thrive in a multi-cultural environmentAble to work flexible hours to accommodate meetings/teleconferences with different time zonesMust 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 degreeBroad 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 desirableExperience working on/leading project teamsDemonstrated 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 levelEmployment type

Employment type Full-timeJob function

Job function LegalIndustries Pharmaceutical ManufacturingReferrals increase your chances of interviewing at Geron Corporation by 2xSign in to set job alerts for “Senior Manager Regulatory Affairs” roles.

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