Manager / Senior Manager – Global Regulatory Labelling
- Location
- Across United States
- Salary
- USD 50 / hour
- Company
- Akash pawar
Job description
Role & Company / Project Overview: We are seeking an experienced Manager / Senior Manager – Global Regulatory Labelling to support Core Labelling for our client, Viatris. The selected professional will have strong hands-on experience in global regulatory labelling, particularly developing and maintaining CCDS, USPI, and EU SmPC documents for assigned pharmaceutical products and portfolios. Key Responsibilities & Daily Duties: • Lead global regulatory labelling activities for assigned products and portfolios. • Develop, review, and maintain CCDS, Target Product Labelling (TPL), and Core Patient Information. • Support regional labelling documents, including USPI and EU SmPC. • Collaborate with cross-functional teams to meet global labelling requirements. • Participate in Product Labelling Teams (PLTs) and Global Labelling Committee (GLC) discussions. • Conduct competitive labelling analysis and regulatory precedent assessments. • Review promotional and non-promotional materials for compliance. • Support NDA, BLA, and MAA submissions and review related regulatory documents. • Monitor global regulatory guidelines and recommend proactive labelling strategies. Required Qualifications, Skills & Experience: • Bachelor's degree in Science, Medicine, Pharmacy, or a related field. • 7–10+ years of Regulatory Affairs experience. • Strong hands-on experience developing and maintaining global core labelling documents, especially CCDS. • In-depth knowledge of global regulatory guidelines and requirements. • Proven experience with global regulatory labelling strategy and product lifecycle management. • Strong cross-functional collaboration and stakeholder management skills. • Eligible Visa status: USC, GC, GC EAD, TN. Preferred Qualifications: • Advanced degree (MSc, PharmD, or PhD). • Experience supporting NDA, BLA, or MAA submissions. • Target Product Labelling (TPL) development experience. • Competitive labelling analysis and regulatory precedent assessment expertise. • Direct experience with PLTs and GLCs. Important Submission Requirements: • Genuine LinkedIn profile only (no recently created or multiple profiles); updated LinkedIn profile picture is mandatory. • Visa copy must be submitted for GC and EAD candidates. • Resume must include complete educational details, including university name and graduation year. Working Hours, Shifts & Location Details: • Location: Remote (USA). • Duration: 6+ Months Contract. • Interview Mode: Video interview. Compensation & Benefits: • Pay Rate: $50/hr on W2. Application Instructions: • Submit resume and required documentation via email or contact recruiting representatives.