Labeling Associate

Job Title: Labeling Associate

Location: Navi Mumbai

Responsibilities:

The Labeling Associate is primarily responsible for the development and/or revision of all Rx/OTC core text documents, labeling artwork, and side-by-side comparisons, as well as the creation of SPLs for the compilation of all FDA Rx/OTC labeling submissions. This also includes the development, revision, or review of all text and graphics for all labels marketed in the US.

Essential Functions and Responsibilities

• Develops and/or revises Rx/OTC core labeling text using appropriate reference or source documents, ensuring compliance with all applicable regulations and company or customer style requirements.
• Creates and revises artwork for Rx and OTC products utilizing graphic software.
• Creates side by side comparisons for submissions.
• Establishes red-line artwork.
• Initiates and compiles required labeling documents for all new Rx/OTC ANDA/NDA submissions, amendments, and/or supplements.
• Prepares full responses to FDA labeling deficiency letters or listed drug updates via a supplement or amendment. This includes but is not limited to coordination of side-by-side comparisons, SPL, and other required submission materials, as necessary.
• Ensures compliance with all SOPs
• Shares responsibility in the maintenance of master labeling text, history, and source files.
• Maintains knowledge of regulations, guidelines, and standard operating procedures applicable to Rx and OTC labeling.
• Electronically monitors the FDA website and the Federal Register. Interprets Federal Register Notices related to the Rx and OTC arena for company personnel and communicates such interpretations to affected company individuals.

Specialized Knowledge and Skills

• Must have a minimum of 3 years of relevant Rx/OTC labeling experience and be able to multi-task in a fast-paced work environment.
• Must have exemplary oral and written communication skills.
• Must be organized with a keen attention to detail
• Must have the ability to work independently as well as in a team environment
• Have knowledge of US FDA regulations regarding creation of labeling and processes for ANDAs and NDAs.
• Must have proficiency with XML, database, and word processing applications as well as Adobe Creative Suite software packages on a PC platform.

Equipment and Applications

• PC, Microsoft Office Suite with a proficiency in Microsoft Word and Microsoft Excel
• Adobe Acrobat Professional
• Knowledge of SPL or equivalent XML application used to create structured product labeling preferred.