Regulatory Affairs Specialist Project Lead I - Washington, United States - Integrated Resources

Integrated Resources Washington, United States

2 weeks ago

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.

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

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:

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

Education, Experience and Skill Requirement:

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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