Regulatory Affairs Strategist

Role: Regulatory Affairs Strategist responsible for developing and executing regulatory strategies to support pharmaceutical product approval and lifecycle management. Main objectives include ensuring compliance, facilitating submissions, and managing regulatory risks across global markets. Responsibilities encompass preparing and submitting INDs, NDAs, BLAs, and post-approval changes; providing regulatory guidance to R&D, Clinical, CMC, Quality, and Commercial teams; managing interactions with regulatory agencies (FDA, international bodies); maintaining submission systems; and leading responses to agency inquiries. Required qualifications include an advanced degree in Life Sciences, PharmD, or Regulatory Affairs, with 5+ years of experience in pharma, biotech, or medical devices, deep knowledge of FDA and global regulations, and proven regulatory submission expertise. RAC certification is a plus. The role demands strategic thinking, attention to detail, and strong cross-functional collaboration skills, with excellent communication abilities. High-value specifics include a focus on US and international regulatory environments, experience with FDA IND/NDA processes, and managing global regulatory strategies. The position may involve working in a dynamic, entrepreneurial setting, with an emphasis on planning, risk mitigation, and stakeholder engagement.