What are the responsibilities and job description for the Regulatory Affairs Director position at Gables Search Group?
Position : Regulatory Affairs DirectorSummary : Lead the development of regulatory strategies and submissions.Collaborate with various departments such as R&D, Technical Operations, Clinical Development, etc. to advance the company’s drug portfolio and ensure its commercial success.Responsibilities : – Provide guidance for development programs in order to meet regulatory standards in the US and globally.– Offer strategic regulatory direction throughout the entire product development process, from concept to market launch.– Shape innovative regulatory pathways that benefit all stakeholders.Requirements : – 7-12 years of regulatory experience within the pharmaceutical / biopharmaceutical industry.– Demonstrated track record of regulatory leadership, including expertise in 505(b)(1), 505(b)(2), 505(j), etc.– Experience in filing and obtaining FDA and international approvals.– Extensive knowledge of regulatory aspects of drug development, including CMC, preclinical, clinical, and post-marketing phases.– Familiarity with FDA and other regulatory bodies’ procedures and requirements.