Regulatory Affairs Associate
Parexel
full-time
Posted on:
Location Type: Remote
Location: Mexico
Visit company websiteExplore more
About the role
- Play a crucial part in coordinating various Global regulatory submissions ie. INDs, IMPDs, BLA/NDS/MAA post-approval commitments
- Assist in the preparation and coordination of global regulatory submissions, ensuring all submissions are complete, accurate, and compliant with regulatory requirements
- Manage submission timelines and coordinate with cross-functional teams to gather necessary documentation
- Support the team in conducting regulatory assessments of manufacturing changes, analyze the potential impact, and assist in preparing documentation to support manufacturing change assessments
- Facilitate effective communication between cross functional teams and regulatory authorities
- Participate and facilitate project team meetings to provide regulatory input and updates
- Maintain accurate and up-to-date regulatory documentation
Requirements
- Strong labeling and artwork experience
- Solid project management skills
- Familiarity with seasonal vaccine activities
- US knowledge required
Benefits
- Health insurance
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submissionsINDsIMPDsBLANDSMAAlabelingartworkproject managementregulatory documentation
Soft Skills
communicationcoordinationteam collaborationanalytical skillsfacilitation