Amneal looking for the Labelling Specialist (Regulatory Affairs)

Experience: 4-8 Years
Job Location: Ahmedabad
Domain: Labelling (RA)

Job Description-1:

· Candidate will be required to work with minimum supervision and possess a strong knowledge of Domestic/ China/ Canada/ LATAM/ Mexico labeling regulations, to the level of applying them effectively to all work output for artworks preparation. 
· Review of artworks & labelling as per requirements of Drugs & Cosmetic Act Rules.
· Keep up to date with national and international legislation, guidelines and customer practices.
· Studying scientific and legal documents for preparation of Artworks.
· Collect, collate and evaluate scientific data from a range of sources.
· Coordinate with different departments for documents required for labeling and review and compile the same.

Job Description-2:

· Candidate will be required to work with minimum supervision and possess a strong knowledge of Africa, MENA, SEA (Southeast Asia), and CIS (Commonwealth of Independent States) labeling regulations, to the level of applying them effectively to all work output.
· Perform quality reviews of labeling and submission documents.
· Work closely with external departments, including CMC team(s) and plant team(s), to align with internal product strategy.
· Maintain an accurate project tracker of all assigned projects with identified due date priorities and timelines of initial assignment, initiation and completion of projects.
· Maintain knowledge of regulations, guidelines, and standard operating procedures applicable to Country specific labeling.

Interested candidates may share their cv at kavitriy@amnealindia.com