Regulatory Affairs Manager / Manager - Regulatory Affairs

World Class pharmaceutical company is seeing a Regulatory Affairs Manager to participate in the development and implementation of regulatory strategies with project team members for submissions. Other responsibilities include; coordinating and supporting all aspects of regulatory submissions for U.S. and Europe. This position will play a major role in reviewing and performing data quality checks on technical and regulatory submission documents as well as internal documents to ensure the proper implementation of regulatory strategies and adherence to appropriate statutes, regulations, and guidelines. The Regulatory Affairs Manager will interact with regulatory agencies as appropriate and perform all duties necessary to comply.

Requirements:

*BS in Chemistry or other Science degree.
* Minimum of 4 years experience within regulatory affairs and regulatory submissions.
*Understanding of the current Regulatory environment and demonstrated ability to perform it.
*Ability to adhere and support regulatory strategies.
* History of successful FDA interactions.
*Demonstrated ability in IND/DNS's/ANDA's/505(b)
*RAC certification preferred but not required.
*Excellent communication and leadership skills.


For consideration, please forward an MS Word resume to; careers@courtneygroup.net Relocation is available for this position.


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