Job Description:

• Oversee 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
• Provide consultation on regulatory aspects during the development phase
• Ensure all 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 related field
• 7–10+ years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry
• Proven track record of leading and successfully managing ANDA, IND, NDA, submissions and approvals with the FDA
• Experience in regulatory strategy 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 mindset
• Excellent communication and interpersonal skills for effective collaboration with internal teams, external partners, and regulatory agencies.

Benefits:

• Remote work options
• Professional development opportunities