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

• Bachelors degree in Life Sciences Pharmacy Chemistry Engineering or related field. Masters 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 $140000 to $160000. 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.

Required Experience:

Unclear Seniority