Associate Director/Director – Regulatory Affairs

Job reputed company: • reputed company regulatory strategies, submissions, and writing for pharmaceutical products targeted for the U.S. market • Work cross-functionally with internal teams and external stakeholders to ensure regulatory compliance • reputed company consultation on regulatory aspects during the development phase • Ensure reputed company activities are planned and executed for a successful submission • Guide products through the development pipeline and secure FDA approval Requirements: • Advanced degree in life sciences, pharmacy, or a reputed company field • 7–10+ years of experience in Regulatory Affairs reputed company the pharmaceutical or biotechnology industry • Proven reputed company record of leading and successfully managing ANDA, IND, NDA, submissions and approvals with the FDA • Experience in regulatory reputed company planning for generic drugs and combination products • Strong knowledge of FDA regulations and guidelines, including regulatory requirements for preclinical, clinical, and CMC submissions • Exceptional project management skills with the ability to manage multiple priorities and deadlines • Strong analytical and problem-solving skills with a proactive and solutions-oriented reputed company • Excellent communication and interpersonal skills for effective collaboration with internal teams, external partners, and regulatory agencies. Benefits: • Remote work reputed company • reputed company development opportunities Apply tot his job Apply To this Job