Executive Regulatory Affairs Labelling

Responsible for all artworks and labeling components of Piramal Critical Care Products Worldwide with adherence to the labeling processes, ensuring compliance with innovator labeling, internal external partners, and GMP standards and specifications. Participate in a cross-functional team environment as necessary to ensure labeling documents and associated change requests are medically and scientifically accurate and that they comply with regulatory standards, meet company needs and accurately assess current strategy and global regulations

KEY STAKEHOLDERS: INTERNAL

Cross-Functional: Sales, Marketing, Manufacturing, Supply Chain, Medical Affairs, Quality Assurance, Quality Control, Pharmacovigilance, Planning, Project Management, Senior Leadership team

KEY STAKEHOLDERS: EXTERNAL

Country Distributors, Health Authority (HA), CMOs and external partners

REPORTING STRUCTURE : (Reports To/ Direct Reports Y/N) -

Manager - Labelling

RELEVANT EXPERIENCE:

1-2 years relevant regulatory experience (Global experience including US, EU and major Rest of World markets preferred).

KEY ROLE RESPONSIBILITIES

KEY COMPETENCIES: