Vice President I, Regulatory Affairs

We are seeking an experienced and strategic Regulatory Affairs leader for the position of Vice President – Regulatory Affairs. The incumbent will lead a large RA organization and drive global regulatory strategies for complex generic and specialty pharmaceutical products across the US, Canada, and EU markets. The ideal candidate must possess strong hands-on experience in post approval submissions, pre-ANDA, pre IND, and pre-NDA activities, along with proven expertise in supporting ANDAs and 505(b)(2) NDAs. This role requires deep regulatory knowledge, leadership capability, strategic decision-making, and cross-functional collaboration to ensure successful regulatory outcomes and accelerated approvals.