Senior Manager, Global Regulatory Affairs

POSITION SUMMARY

The Senior Manager, Global Regulatory Affairs provides regional (EU and other ex-US countries) support for all regulatory activities related to the ongoing development, registration, and life-cycle management of Imetelstat and future Geron development product candidates. This position holds supportive responsilbilities including, but not limited to 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 reports directly to the Director (EU lead) Global Regulatory Affairs. This is a remote based position located in the United Kingdom.

REQUIREMENTS/QUALIFICATIONS

Key Competencies:

  • Responsible for the preparation and provides review and input on documents for submission to regional regulatory agencies
  • Contributes to the preparation of registration dossiers and CTA packages
  • Works with regulatory team members and functional subject matter experts to build and maintain the content plan for MAA and CTAs, etc. to ensure timely delivery of submission components
  • Works with EU Lead and project teams to develop regional marketing approval submission plans and timing
  • Oversees management of responses to questions from regional regulatory agencies in a timely manner and in line with the product strategy
  • Contributes to the management of product lifecycle submissions (e.g., DSURs, IB, ODD Annual Reports)
  • Works effectively with any Geron vendor to successfully execute above activities
  • Ensures that appropriate, up-to-date records are maintained for compliance
  • Understands regional and local requirements and advises 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
  • Supporting additional regulatory projects (e.g., conducting due diligence, supporting regulatory new initiatives) as needed
  • Assists in development of regulatory standards and SOPs
  • Undertakes necessary training and is able to work effectively within Geron regulatory document management systems and processes (Veeva RIM)
  • 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 Director, Global Regulatory Affairs (EU Lead)
  • Provides input into the development of regional product labelling as needed
  • Engages Head of Regulatory, regulatory colleagues and representatives from other development functions to enable execution of regional strategies as appropriate

 

EXPERIENCE AND COMPETENCIES

The successful candidate will be able to demonstrate the following:

  • A minimum of Bachelor’s degree (or equivalent) in a scientific discipline required, advanced degree (MS, PhD, MD or PharmD) highly desired
  • A minimum of 5 years of relevant progressive regulatory experience
  • Breadth of global regulatory affairs experience in drug development and commercialized products (for example, experience in a therapeutic area, multiple phases of drug development) is required
  • Broad regulatory experience in EU geographic region preferred (experience across all phases of development) with prior global regulatory exposure/experience.  Experience with the centralised procedure is also desirable
  • Strong 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
  • Demonstrated contribution to drug development projects and implementation of strategies is desirable
  • Demonstrated ability to handle multiple projects, excellent verbal and written communication skills, ability to work and thrive in a multi-cultural environment, and ability to work in a matrix environment are required
  • Experience in working/leading project teams; demonstrated project management skills is required
  • 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, which may require travel to London Potential occasional travel may be required to the US