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.