Regulatory Affairs Consultant – Labeling Operations
Parexel
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Apollo
About the role
- Manage internal global labeling and drug safety activities and coordinate bi-weekly updates with leadership.
- Coordinate readability testing (planning, team review, and communications).
- Oversee translations for foundational markets (EU, CH, DE).
- Coordinate and upload CH labels to AIPS; submit approved labels to external platforms (HA, ePIL).
- Upload approved labels to internal systems (Documentum, Weblabel, intranet).
- Manage linguistic reviews and dispatch CCDS, foundational labels, and multi-market manuscripts to stakeholders.
- Lead impact assessments for technical and global labeling changes across dependent markets.
- Perform data entry in Trackwise/Veeva and prepare annual labeling reports.
- Review and update submission content plans; prepare change control documentation for CCDS-driven changes.
- Prepare and manage Structured Product Labeling (SPL).
- Support advertising and promotional and marketing material reviews, educational materials, and social media compliance.
- Ensure compliance with country-specific regulatory requirements.
- Act as key partner to GRA Regions, Regulatory CMC and Supply Chain.
Requirements
- University degree in Life Sciences, Chemistry, Engineering, or related pharmaceutical field; advanced degree (MSc, PhD, PharmD) preferred.
- Minimum 5 years of biotech/pharma industry experience, including 2+ years in labeling/regulatory operations with global responsibility.
- Experience leading teams in a matrix organization.
- Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management.
- Experience with flu campaigns, pandemic products, and direct-to-consumer advertising.
- Familiarity with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, Trackwise, and other regulatory systems.
- Proficiency in Microsoft Office, SharePoint, Adobe Acrobat, TVT, PromoMats, GLAMS.
Benefits
- Competitive compensation
- Benefits
- Opportunities for career growth
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
labelingdrug safetyreadability testinglinguistic reviewsdata entryStructured Product Labelingchange control documentationregulatory labeling lifecycle managementcompliancebiotech/pharma industry experience
Soft skills
team leadershipcommunicationcoordinationorganizational skillsstakeholder management
Certifications
University degree in Life SciencesUniversity degree in ChemistryUniversity degree in EngineeringMScPhDPharmD