Interact and negotiate with drug regulatory agencies (US and non-US) on assigned projects and manages the project activities of other regulatory staff assigned to projects under their authority. • Serves as the primary Regulatory Affairs representative to assigned Product Development Teams(s) and interacts with other departments and with personnel from corporate partners. • Participates in development of overall project goals and in particular those that pertain to regulatory affairs. • Develops regulatory strategies and position papers for development candidates submissions drug regulatory agency meetings and special regulatory issues. • Responsible for negotiations and interactions with drug regulatory agencies on assigned projects. • Coordinates preparation of information and development of strategies for meetings with drug regulatory agencies. • Responsible for managing the conduct of meetings when appropriate and responsible for meeting minutes. • Responsible for organizing regulatory submission teams and coordinating the drafting editing and preparation of regulatory submissions (e.g. IND’s NDA’s annual reports IND amendments NDA supplements routine correspondence). • Participates in the development implementation and enforcement of regulatory policy. • Negotiations with and supervision of contract organizations employed for the preparation of regulatory submissions. • Advises relevant corporate personnel regarding regulatory strategies potential areas of concern and new governmental/regulatory developments. • Determines methods and procedures that are to be followed for projects assigned and may manage the activities of other regulatory staff assigned to their projects. • Responsible for the regulatory evaluation of in-licensing candidates as assigned. Discretion/Latitude/Independence
REQUIREMENTS: • Graduate degree in pharmacy life science or commensurate experience. • 5+ years of related experience with at least 4-5 years of Regulatory Affairs experience with increasing responsibility. • A Master’s Degree or PhD may partially substitute for work experience. Experienced in the process of interacting with regulatory authorities. • Knowledge of ICH/GCP GLP and GMP requirements. • Must be able to effectively interact with internal and external customers to obtain accurate information and be a team player. • Must posses the ability to manage multiple projects with competing deadlines. Compensation: The salary and benefit package will
• EDUCATION: Graduate degree in pharmacy or life science
• JOB DURATION: This job is full time and long term.
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