Senior Manager, Labeling & Regulatory Affairs
Core
Develop and implement labeling and regulatory strategies for new drug development, global applications, and marketed products to ensure business continuity and regulatory compliance.
Role type
Senior Manager, Regulatory Affairs (Labeling)
Builds
Regulatory approval dossiers, labeling drafts, post-marketing applications, and compliance documentation for pharmaceutical products.
Domain
Pharmaceuticals / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory strategy, stakeholder management, cross-functional leadership, post-marketing application management, global regulatory alignment, packaging compliance, strategic negotiation, problem-solving, analytical thinking, English communication.
Preferred skills
Knowledge of R&D processes, familiarity with local and global regulatory organizations, facilitation skills, adaptability to environmental changes.
Responsibilities
Lead labeling strategy across development, approval, and maintenance stages; coordinate with internal and external stakeholders; prepare and submit post-marketing applications and notifications; ensure compliance of packaging materials; coach and train staff; improve inter-organizational processes.
Seniority
Senior, hands-on IC with leadership responsibilities