- 3-6 years of experience in pharma regulatory-related roles across all therapeutic areas
- Fluent in online searches and research
- Proficient in MS Office applications
- Ability to create presentations
- Work with regulatory leads on product strategy and FDA engagement
- Monitor emerging regulatory policy issues
- Coordinate internal teams to develop responses on regulatory issues
- Lead advocacy efforts for regulatory policy areas
- Minimum B.S.; M.S., Pharm D, MD, PhD or equivalent preferred
- Minimum 3 years in Regulatory Affairs
- Familiarity with drug/biologic development process
- Excellent communication and organizational skills
- Ability to lead multiple initiatives effectively
- Self-motivated and results-oriented
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Regulatory Affairs Specialist Project Lead I - Washington, United States - Integrated Resources
Description
Job Title:
Regulatory Affairs Specialist Project Lead I
Location:
Washington D.C., DC (Fully Remote)
Duration: 06 months
Part-Time Role- (Mon - Fri 9 AM - 1 PM EST)
Job Description:
Fully Remote Part-Time Role with slight flexibility for different time zones. Candidates must be located in the US. Possibility of extension.
Nice to Have Skills:
Writing, analyzing data, research write-ups.
Product Responsibilities:
Accountable for supporting regulatory policy efforts within the Regulatory Science and Policy team. Responsibilities include working with cross-functional teams on strategic and tactical product issues, FDA engagement, and ensuring effective execution for new products.
Duties:
Education, Experience and Skill Requirement: