Location: San Francisco
Closing Date: 19 Jan 17
Salary (£): Negotiable
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. ...
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.
* 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:
* Experience working on promotional materials and with OPDP (formerly DDMAC).
* Experience with US and international management of post-marketing CMC changes
* Experience in pediatric drug development and understanding of US and EU regulations related to pediatric requirements
* Experience in the management of core labeling and/or US labeling
* Understanding of regulatory requirements for and experience with submission of applications (IND / NDA) in eCTD format
* Ability to create and manage detailed timelines and/or experience with tracking regulatory activities across disciplines and territories
* 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
4th Floor, 150 Leadenhall Street, London
|Tel:||+44(0)203 327 3072|
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