Cornerstone Search Group has been retained by a multibillion-dollar global pharmaceutical company [with products including Innovative Rx (BLAs & NDAs), 505(b)(2)s (e.g., injectables, inhalers), Biosimilars, and Generics (ANDAs)] for a key strategic VP position that serves as the Head of their large North American Regulatory Affairs organization.
In collaboration with the product strategy teams, this Vice President and their North American Regulatory Affairs (RA) organization are responsible for the implementation of regulatory strategy for the USA and Canada across the company’s entire portfolio of branded (BLA / NDA / 505(b)(2) / biosimilar) and generic products. This Head will provide oversight, counsel, and guidance to RA staff members for day-to-day operations and to RA staff and other functional areas for the planning, preparation, review, and evaluation of documents for submission to the FDA and Health Canada. This organization is responsible for ensuring that all regulatory requirements and commitments are met with respect to obtaining the approval of new products and for maintaining the approval of currently marketed products.
COMPENSATION: Our client has highly-competitive compensation programs including a very attractive long-term incentive stock program.
KEY DUTIES AND RESPONSIBILITIES:
DESIRED SKILLS / QUALIFICATIONS / EXPERIENCE / BEHAVIORS:
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