Senior Regulatory Affairs Consultant – Labeling
Location
United States
Posted
89 days ago
Salary
Not specified
Seniority
Senior
Job Description
Job Requirements
- Bachelor’s degree in Life Sciences or related field; advanced degree (MSc, PhD, PharmD) preferred.
- 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).
- Fluency in English (verbal and written); additional languages would be an asset.
Benefits
- Health insurance
- Flexible work arrangements
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