Overview

Reference Number: JO-2103-464331_2
Senior Director / Director of Regulatory Affairs
Rate: Negotiable
Job Type: Permanent
Location: San Francisco

Senior Director / Director of Regulatory Affairs
Location: San Francisco / Home-working
Salary: Highly competitive and dependant on experience
Job Reference:

We have an exciting opportunity available with an expanding pharmaceutical company based in San Francisco. In this role, you will be responsible for providing strategic leadership for a developing portfolio and be the primary FDA contact for the business. This is a great opportunity for an experienced professional to join a collaborative and growing business on apursuit to improve the lives of people living with cancer

Responsibilities include
Preparing and/or directly and submitting all the required submissions to FDA in support of clinical trials and marketing applications
Updating and preparing the Company for major changes legislation for assigned territories
Developing and implementing regulatory strategy and managing complex negotiations with Regulatory Authorities.
Coordinating with European/ROW Regulatory Affairs group for global regulatory strategy and submissions.

Experience
10+ years experience working within Regulatory Affairs
Degree in a scientific field
Extensive knowledge of regulatory drug development activities, Oncology experience preferred.
Ability to manage multiple projects
Experience working with FDA

If you would like to apply for this position or discuss any of our other active positions please contact Charlie on Charlie.harris@cpl.com or https://www.linkedin.com/in/charlie-harris-5b2992ba/