Position: Senior/Executive Director, Regulatory Affairs Job #2102
Location: Westchester, NY
Compensation: $220k++ +bonus +LTI
This management position in Regulatory Affairs involves the ability to lead and manage the regulatory affairs organization so that all corporate objectives are met within specified timelines and so that the necessary state of compliance is maintained relative to all regulatory commitments/requirements. In addition, the position assists corporate senior management in understanding Regulatory strategies/processes while developing corporate objectives and, importantly, understanding the impact of decisions across therapeutic areas.
Duties & Responsibilities:
Responsible for regulatory strategies for all development programs to ensure Regulatory Agency approval(s) within specified timelines of all activities in support of the company’s corporate development and marketing objectives:
Manages liaisons and/or provides direction to regulatory representatives to project teams who effect and communicate regulatory strategies in consultation with the Executive Director.
Review critical regulatory communications. Evaluate conformance with the regulatory requirements, clarity, and completeness.
Responsible for ensuring necessary state of compliance for all regulatory commitments/requirements:
Supervises/manages others to ensure that all reporting requirements and other commitments are met with respect to INDs, BLAs, CTA, MAAs, etc.
Supports department liaisons with their project specific communications, including Agency meetings.
Responsible for the completeness and accuracy of information provided in regulatory submissions.
Supervises regulatory staff with the planning, preparation and submission of all regulatory documentation.
Permanent member of PRC and RCRC.
Responsible for the planning, preparation and submission of licensing applications:
Manages liaisons and/or provides direction to regulatory representatives to project teams who effect and communicate to multidisciplinary teams the content, format, style architecture and timing of a Biologics Licensing Application (BLA) and MAA.
Review application. Evaluate conformance with the regulatory requirements, clarity, and completeness.
Supervise Regulatory staff with respect to commercialization activities associated with new product registrations.
Responsible to senior management for timelines/budgets.
Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs.
Provide training on applicable requirements for scientific staff as required
Requires advanced degree in a science related discipline.
A minimum of 15 years of pharmaceutical industry or related experience, at least 5 of which should include regulatory experience.
Research laboratory, process development or manufacturing experience with biotechnology products highly desirable.
Must possess excellent written and verbal communication skills.