Job Scope & Purpose:
Our client is a commercial-stage biopharmaceutical company seeking an exceptional Regulatory Affairs Strategist at a Director or Associate Director level to help drive compounds in all phases of development forward to treat patients with a rare genetic disease. The Director, Regulatory Affairs will lead the implementation of regulatory strategy and programs within the project teams for assigned products and represent the company at FDA and EMA regulatory agencies. The qualified candidate will possess hands-on experience in preparing regulatory submissions (e.g. INDs, NDAs, CTAs, MAAs) reports and correspondence to the appropriate regulatory agencies and lead regulatory affairs cross-functional sub teams for assigned projects.
Primary Job Responsibilities:
In collaboration with key stakeholders, formulate regulatory strategies that provide a streamlined development programs while accurately interpreting and reflecting regulatory and corporate guidelines.
Plan and manage integration of multidisciplinary regulatory programs into the project team development plans for all assigned projects
Lead the planning and conduct of meetings with regulatory agencies as appropriate and may represent at regulatory agency meetings as appropriate
Provide current and proposed regulatory, scientific and pertinent legal issues (i.e., external meetings, workshops and conferences).
Ensure that all documents to be submitted to regulatory agencies have been evaluated to assure that they are complete, well organized, and scientifically accurate, of high quality, are in regulatory compliance, and are presented in a way that facilitates agency review.
Primary Job Requirements:
Advanced scientific degree preferred. B.A. or B.S. or higher degree(s) in the sciences, or health related field minimum, with 7+ years of regulatory experience.
Demonstrates personal leadership and collaboration skills.
Demonstrated knowledge of drug development process is essential. Knowledge of laws and regulations affecting the pharmaceutical industry, and regulatory experience.
Must have prior experience working with FDA or EMA.
Experience of successful NDA, BLA or MAA in filing essential.
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