Assistant Manager/ Deputy Manager - Labelling

Adept at identifying, addressing, and escalating issues promptly to ensure resolution.

Familiar with Regulatory Information Management (RIM) systems like Veeva Vault and/or similar platforms.

8-12 years of pharmaceutical labeling experience.

Responsible for development and implementation of new and revised pharmaceutical drug product labeling for both pipeline and commercial products across global market (including FDA, EMA, Health Canada, GCC, APAC, LATAM, and other emerging regions) ensuring compliance with applicable regulations, guidelines, and company standards.

Oversee regulatory labeling activities across the entire product lifecycle from development through post-approval, ensuring timely submissions and adherence to international health authority requirements.

Act as a subject matter expert for global labeling regulations, standards and best practices.

Initiate and monitor the process for new and revised labeling requests according to internal procedures.

Prepare and update labeling components such as SmPC, PIL, USPI, carton/container labels, and electronic formats (e.g., SPL, XML) for global submissions.

Ensure regulatory compliance, accuracy, and version control of all new and revised labeling.