Description
My client is currently seeking a Manager, Clinical Regulatory Affairs. This position will manage the Clinical Regulatory Affairs function of the company to ensure regulatory compliance. This role reports directly to the Executive Vice President, Manufacturing Operations and Regulatory Affairs.In this hands-on role, the Manager, Clinical Regulatory Affairs will be responsible for:
- Determining clinical requirements for submission of Investigational New Drug (IND) applications in the US and for clinical trial applications outside of the US, e.g. CTA, CTD, IMPD, ATMP's
- Preparing documentation for new clinical trial submissions and for managing and maintaining existing clinical trial submissions
- Preparing and submitting annual reports, final study reports and other reports as required for ongoing compliance
- Interfacing with FDA and ex-US regulatory agencies to schedule meetings, submissions and respond to inquiries/questions
- Working with Senior Management to formulate strategy for product filings and approvals
- Interfacing with internal Clinical Operations, Manufacturing Operations, CMC Regulatory and Quality Assurance groups to ensure ongoing compliance and coordination of information for submissions, amendments and reports
- Maintaining compliance by monitoring tracking and controls systems and preparing and updating policies and procedures
- Utilizing both electronic and hard copy data to establish and maintain regulatory information systems and regulatory submissions
- Participating on CAPA (Corrective and Preventive Action) and Material Review Board teams during investigations and processes
- Tracking domestic and international regulatory developments and advising the company on the same
- Other duties as may be assigned
Candidate must possess:
- BS Degree or equivalent qualification
- At least 5 years of relevant experience of Clinical Regulatory Affairs in the biotechnology industry
- Proven track record managing the clinical regulatory affairs function
- Experience with the submission and ongoing management/reporting of IND, BLA, CTA and IMPD applications is essential
- Excellent interpersonal and communication skills
- Proven track record of success in leading and managing execution of the clinical regulatory components of complex multi-faceted projects in a fast-paced environment
- Expert knowledge of FDA and International
To find out more about Real please visit www.realstaffing.com