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

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