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Advanced degree in Life Sciences, Pharmacy, Medicine, or related field, with a minimum of 3-5 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization industry.

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 

Must have experience in the Nutraceutical Industry. Good knowledge of FSSAI regulations, product registration & regulatory documentation.

Coordinate with cross-functional teams, including Clinical, Quality, and Manufacturing, to gather necessary regulatory documentation.

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

Responsible for the drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs.

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