5+

Bachelors degree in Regulatory Affairs, Science, Life Sciences, Healthcare. Author and maintain regulatory documentation including technical documentation, declarations, regulatory assessments, intended use statements, labeling reviews, and compliance records.

The Acme Group began its journey in 2005 with a bold mission of becoming a leader in the contract manufacturing space and a preferred business partner for pharmaceutical companies seeking world-class capabilities and scalable operations.

Experience in preparation/review of PSURs/PBRERs, PADERS, Signal Evaluation Reports, and Risk Management Plans

Regulatory Compliance Management. Product Registration & Lifecycle Management. Cross-Functional Stakeholder Management 

Awareness about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames and submissions.

Review and assess local country labels to identify deviations from the core labeling and propose topics for further cross-functional assessment during the periodic core labeling review process

Experience in Media Preparation, MLT, BET, sterility method validations, execution, documentation preparation, and review.  NATCO - Walk-In Interview. Production, Engineering, QC, Microbiology and QA

Experience in Literature Survey, Identification of route of synthesis, Process Optimization with respect to cost & quality, Scale-up, Documentation & Characterization

Hands-on experience in Bag Filling Machine, preferably SHINVA Bag Filling / PLUMAT. Handling complex manufacturing processes such as Emulsion and Suspension.