Senior / Regulatory Affairs Consultant - Regulatory Labeling Strategist
RemoteUnited States
Job Summary
Define global labeling strategy across US, EU, AU, CH, and DE markets, leading governance committees and cross-functional teams to deliver compliant documentation throughout the product lifecycle. Chair Labeling Review Committees, manage core documents like the CDS and USPI, and interpret clinical data to inform product claims while ensuring FDA Section 508 accessibility. Oversee operational activities including artwork coordination, linguistic reviews, and Health Authority negotiations, maintaining documentation within eDMS systems. Prepare RFIs, track differences, and manage annual flu strain updates and Drug Listing Reports. Work across diverse markets to support safe and effective global product use.
Required Qualifications
- Bachelor's degree in Life Sciences or related field
- 5-7 years in biotech/pharmaceutical industry
- 2+ years in global labeling/regulatory with global strategic leadership responsibilities
- Proven ability to lead cross-functional teams and influence stakeholders across diverse cultural and geographic settings
- Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management
- Experience with direct-to-consumer advertising, social media review, and Health Authority negotiations
- Must be familiar and able to work with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, and Change Management systems (e.g., Trackwise)
- Experience with Microsoft Office applications, SharePoint, Adobe Acrobat, TVT, Promomats, and GLAMS
- Knowledge of regulatory requirements relevant to drug development, global labeling, and post-marketing (US, EU, AU, DE preferred)
- Demonstrated problem-solving ability with risk analysis and sound decision-making
- Strong collaboration skills, with experience working in global, cross-cultural, matrix environments
- Organizational skills to interact seamlessly both internally and externally on compliance matters
- Proficient regulatory knowledge, including scientific concepts within labeling and their global implications
- Effective communication skills for explaining concepts, options, and impacts
- Attention to detail with the ability to think strategically
- Fluency in English (verbal and written)
- Candidates located in the EST time zone
Desired Qualifications
- Advanced degree (MSc, PhD, PharmD)
- Additional languages
- Candidates in other U.S. time zones who have the flexibility to provide coverage during EST hours
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