We are on the lookout for a passionate Subject Matter Expert (SME) with 5 to 10 years of experience in FDA-related roles to volunteer in updating or revamping our FDA Law and Regulation course content. This crucial course, last refreshed in 2017, offers an in-depth exploration of the FDA and its foundational laws and regulations but now requires an experienced hand to ensure it accurately reflects the most current regulatory landscape.
Course Overview:
This course serves as a comprehensive guide on:
- The origins of FDA’s authority and its development over time.
- Compliance obligations across different product categories.
- Outlining prohibited acts under the Federal Food, Drug, and Cosmetic (FD&C) Act.
- Actions the FDA may initiate against FD&C Act violations.
- Insights into ongoing FDA regulatory reforms.
- Efforts toward establishing a globally harmonized regulatory framework for food, drug, device, and cosmetic products.
Volunteer Role Expectations:
The selected volunteer will play a critical role in:
- Conducting a thorough review to determine the current state of course content.
- Identifying and implementing necessary updates or overhauls.
- Integrating recent advancements in FDA regulations and policy shifts.
- Expanding the course to encompass recent FDA regulatory reforms and global harmonization efforts.
Volunteer Specifications:
- Should have 5 to 10 years of specialized experience with FDA regulations.
- Must possess an in-depth understanding of FDA laws, regulations, and compliance mandates.
- Should be well-versed in the historical and evolving landscape of FDA authority and regulatory changes.
- Must exhibit strong research, analytical, and content development skills.
- Should be driven by a passion for educational excellence and knowledge sharing.
Key Details:
- Number of Volunteers Needed: One
- Application Deadline: March 8
- Project Duration: March 15 to May 15
- Incentive: Volunteers will receive a Regulatory Affairs Certification (RAC) upon successful completion of the project.
This opportunity is ideal for regulatory affairs professionals seeking to impact how their peers understand and implement FDA laws and regulations. By volunteering, you'll contribute significantly to the ongoing education and professional growth within the regulatory affairs community.
Interested individuals are encouraged to apply by submitting their resume and a brief statement of interest, particularly highlighting their experience and contributions within the realm of FDA regulatory affairs.
Join us in this fulfilling project to maintain the relevance and accuracy of this essential educational resource. We look forward to welcoming your expertise and enthusiasm to our team!