FDA Licensing and Compliance Advisor

BakerHostetler is seeking a Licensing and Compliance Advisor to join our Washington, D.C. office. The ideal candidate will have a strong background in pharmacy licensing and compliance and FDA regulatory matters, with specific experience advising on pharmaceutical applications and compliance. Responsibilities Advise on FDA regulatory matters impacting pharmacy and pharmaceutical sectors, including compliance with FDA guidelines, labeling, advertising, and promotional requirements. Provide guidance on federal and state laws governing pharmacy operations, drug development, and distribution. Assist with the FDA approval processes, including new drug applications, compliance audits, and post-market surveillance. Review agreements related to pharmaceutical manufacturing, distribution, and consulting. Conduct legal research on regulatory issues. Collaborate with the FDA attorneys regarding regulatory and compliance matters. Qualifications Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Engineering, or related field. Master’s or PhD preferred. 5 - 10 years of experience in regulatory affairs, FDA compliance or a related field. Experience with FDA submissions, licensing requirements, and interacting with regulatory authorities. Excellent written and verbal communication skills. Ability to manage multiple projects and deadlines in a fast-paced environment. Strong communication and interpersonal skills as well as the ability to work effectively in a team-oriented environment. Benefits The expected annual salary for this position ranges from $140,000 to $160,000. determined by factors including experience, education, and relevant skills. Advisors participate in a performance and hours-based bonus program. Comprehensive healthcare benefits, including health, dental, and vision insurance. Generous paid time off (PTO) and holidays. #J-18808-Ljbffr BakerHostetler Career