Job Details
Meet's partenered with a global pharmaceutical manufacturing company on an exciting new search for an Associate Director, Global Regulatory Labeling!
You'll be serving as the GRA labeling experit for the Global Regulatory Team and independently provide strategic and operational leadership on product labeling, address labeling issues at a global level for late-stage projects, manage multiple projects and collaborate with functional leaders, and ensure labeling complies with all regulatory guidelines.
Responsibilities:
- Act as point of contact for cross-functional teams on global labeling issues, development, and approval for either US or EU.
- Independently manage and prepare regulatory documents.
- Ensure compliance and manage updates with Core Data Sheets / Label Changes. Manages US / EU and local country labeling deviations from CCDS.
- Conduct level review committee meetings.
- Ensure compliance with labeling regulations and guidance.
Qualifications:
- Bachelor's degree required. Masters, PharmD, PhD, MD, or JD preferred
- 7+ years in the pharmaceutical industry required.
- 4 years in regulatory affairs.
- Experience with global labeling.
- Ability to travel up to 10%
If you're interested in hearing more about this opportunity please apply or send your resume to ...@peoplewithchemistry.com