Prerequisites: BS Degree with 5-7 years pharmaceutical experience.

Responsibilities will include, but are not limited to, the following:

·         The position will be responsible for coordinating the deliverables and submitting (including electronic) IND/NDA annual reports in accordance with FDA regulations and guidance.

·         Collaborate with internal disciplines such as Clinical R&D, Nonclinical, Early Drug Development, Chemistry, Manufacturing and Controls (CMC) and Regulatory Affairs to obtain missing information and correct erroneous information that is intended for submission.

·         Manage and develop up to 8 Regulatory Operations Staff Members.

·         Develop and promote use of appropriate document policies and standards to create "submission-ready" documents.

·          Manage other Regulatory Operations department activities as required.

·         Responsible for the quality of submissions generated by Regulatory Operations.

·         Represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.

·         Define electronic document/data management and submission processes. Responsible for coordination, implementation and ongoing improvement of these processes.

·         Develop training materials and provides training to internal and external personnel on regulatory operations processes including document management and publishing systems.

·         Respond to regulatory authorities regarding electronic submissions.

·         Address internal or external inspections of documentation and publishing systems.

Skills/Knowledge Required:

• BS Degree with 5-7 years pharmaceutical experience
• Knowledge and understanding of pre and post-marketing regulatory requirements in the US, Europe and rest of world.
• Experience with an electronic document management system and/or workflows
• Excellent organizational, communication and time management skills