Senior Executive Regulatory Affairs

Job Description

Key Responsibilities: Preparing and submission of Sterile Finished Product application CT-10, CT-12, CT-16, CT-21, Form-30, Free sale certificate, Certificate of Pharmaceutical Product, WHO-GMP. Endorsement of Sterile product under the manufacturing licence. Licensing to State drug controller & for getting the licence within a time period given by management. Submission of IND & NDA application of biological products (Cell lines/Tissue Engineered products) Compilation & review of Dossier according to CTD Modules (Module -1,2,3,4 and 5). Review the CMC documents of new product development. Compilation and review of Medical device(s)- Device Master Files. Preparation of the dossier as per checklist of CDSCO MD Rules 2017. Submission of WholeSale & Retails Licence. Labelling and Implementation of Medical Devices, Drug product, Biological product & Cosmetics products. Requirements: Education: Bachelors/Masters degree in Pharmacy, Life Sciences, or a related field. Experience: 3-5 years in Regulatory Affairs within the pharmaceutical, biologics, or medical device industry. Skills: Knowledge of CDSCO, WHO-GMP, and CTD guidelines, experience in dossier preparation & regulatory submissions, strong coordination skills, and understanding of Medical Device Rules 2017. Important Note: "For the first 6 months, the training will be at the Head Office located in Chennai. Travel expenses and accommodation will be provided by the company." Contact us; Siva - 7826802077 Email Id - azaruddin.a@lifecell.in sivaprasad.m@lifecell.in