Senior Manager/Associate Director Global Regulatory Affairs
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POST DATE 9/11/2016
END DATE 10/12/2016
JOB DESCRIPTIONThe Position
X4 is an innovative, clinical-stage biotechnology company located in Cambridge, MA dedicated to developing novel immunotherapies primarily for the treatment of cancer. The company is developing therapeutics designed to improve immune cell trafficking and increase the ability for T-cells to track and destroy cancer cells. X4 is seeking a regulatory professional to manage the global regulatory strategic plan for development of X4P-001, which is the lead CXCR4 antagonist that is currently in Phase 1/2 clinical trials. Reporting to the Vice President of Global Regulatory Affairs and Quality Assurance, this individual must possess excellent communications skills and judgment, demonstrate leadership and guidance while remaining a solid team player.
Description of Responsibilities
Accountable and responsible for evaluating and ensuring that the IND/IMPD meets all global regulatory requirements throughout the drug development process. Ensures that safety reporting requirements, annual reporting and routine updates are met within the regulatory timeframes.
Represent regulatory affairs at various clinical trial team meetings and provide regulatory content reviews of clinical documents, such as new or revised protocols, patient informed consent forms, investigator s brochures.
Lead the development and maintenance of global regulatory strategy documents and target product profiles to support new marketing application planning and development. Research regulatory precedence of prior approvals, clinical trial endpoints and compare competitor labeling documents.
Consistently and proactively research and learn FDA and EMA regulation, guidance and standards to anticipate and resolve regulatory and clinical development questions, as needed, throughout the drug development process. Provide timely dissemination of regulatory intelligence, as appropriate to continually educate and inform project team(s).
Implement and oversee the global regulatory submissions operations function working with a vendor to ensure that all electronic submissions meet global regulatory standards, including the development of submission content plans, submission component development, compilation, and quality checks of documents prior to submission to regulatory agencies. Maintain and update regulatory files to ensure chronologies remain in good order and implement a system for tracking global IND/IMPD submissions and changes.
Responsible and accountable for communicating and driving timelines, risks, and ensuring that submission components are completed within the expected timeframe. Provide regulatory support in drafting responses to global agency requests for information, and briefing document development for Agency meetings, and ensure that next level management remains apprised of any changes to the plan along the way.
May supervise regulatory affairs consultants, as required.