Sr. Director, Regulatory Affairs - South San Francisco, CA | Biospace
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Sr. Director, Regulatory Affairs

Theravance Biopharma US, Inc.

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Location:
South San Francisco, CA
Posted Date:
2/13/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Director, Regulatory Affairs,

Job Description

Job Purpose
The Regulatory Affairs Professional (Director) will be responsible for the comprehensive management of regulatory aspects of the company’s development projects while actively contributing as a member of the project team(s).  This position will also require key contributions to department and company initiatives related to regulatory affairs operations and strategy.

Duties and Responsibilities
•   Responsible for working with the project team to identify an optimum regulatory strategy for assigned projects. Able to lead teams in examining regulatory strategy options.
•   Expected to independently interact with regulatory authorities, and outside consultants when needed. Able to independently prepare and lead a team through a regulatory meeting exercise.
•   Able to write, review and edit regulatory documentation, ensuring it is fit for purpose, and to serve as a resource for regulatory document authors regarding the appropriate content of submissions.
•   Supervises and provides guidance to other regulatory personnel as assigned.

Requirements

•   Education: Minimum Bachelor’s degree; studies in science and advanced degree desirable
•   Specialized knowledge that would be desirable and supportive of success in this position includes:
    o   Experience working on promotional materials and with OPDP (formerly DDMAC).
    o   Experience with US and international management of post-marketing CMC changes
    o   Experience in pediatric drug development and understanding of US and EU regulations related to pediatric requirements
    o   Experience in the management of core labeling and/or US labeling
    o   Understanding of regulatory requirements for and experience with submission of applications (IND / NDA) in eCTD format
    o   Ability to create and manage detailed timelines and/or experience with tracking regulatory activities across disciplines and territories
    o   Experience in other key functional areas, (e.g., toxicology, pharmacology, chemistry/manufacturing, clinical research and/or biometrics) appreciated
•   Experience: Minimum 10+ years progressive Regulatory Affairs or relevant experience