Offer summary
Qualifications:
Bachelor's degree in pharmacy, biology, chemistry, or related field; advanced degree preferred., Minimum of 5 years of experience working at the FDA in a regulatory role, with expertise in drug, biologic, or medical device regulation., Deep understanding of FDA regulations, guidance documents, and regulatory processes related to drug, biologic, and medical device development and approval., Proven track record of successful interactions with the FDA, including experience in preparing and submitting regulatory applications and participating in FDA meetings., Excellent communication and interpersonal skills, with the ability to effectively convey complex regulatory concepts and requirements to clients and internal stakeholders..
Key responsabilities:
- Provide expert regulatory guidance and strategic advice to clients on FDA regulations, policies, and procedures related to drug, biologic, and medical device development and approval.
- Review and interpret FDA guidance documents, regulations, and policies to ensure compliance and facilitate successful regulatory submissions.
- Support clients in preparing and submitting regulatory applications, conduct regulatory assessments, and assist in FDA meetings.
- Monitor regulatory trends, changes, and updates from the FDA and provide insights and recommendations to clients.
- Serve as a liaison between clients and regulatory agencies, addressing challenges, and facilitating communications.