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Regulatory Affairs Specialist

7.00 to 10.00 Years   Mumbai City   07 Sep, 2022
CERENTRAL CONSULTANTS PVT LTD
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaQuality (QA-QC)
EmploymentTypeFull-time

Job Description

    Roles and Responsibilities:Ensure legal compliance with Indian regulatory agency policies, regulations, and standards products.Review product label elements: ingredient legends, claims, safety elements and compliance references as per legal metrology, FSSAI, and otherapplicablelaws.Should be well versed with the preparation of documents forregistration of Probiotics and Nutraceutical productsand for licensing.Evaluate raw material for acceptable use: GMO/non-GMO, nutritional, allergens, origin, contaminates and pesticide compliance.Research and identify appropriate government citations for material use in Indian marketsAct as key internal and external customer contact regarding regulatory inquiries: nutritionals, GMO status, quality questionnaires and product specificationsApply technical knowledge to generate statements on regulatory compliance for existing productsSupporting SCO in importing and exporting regulatory requirements like Health certificate, Free sale certificate, NOC from Drug, Plant quarantine, Animal quarantine departments.Desired Candidate Profile:Cultural awarenessScientific knowledge sufficient to understand regulatory issues and facilitate scientific discussionsComputer skills including MS Office programs such as Outlook, Word, Excel PowerPoint.Strong interpersonal skills and ability to communicate (verbal/writing) effectively.Ability to collaborate across other functional areas.Ability to maintain a high level of confidentialityPreferred knowledge of the Consumer Product Goods IndustryAbility to work independently and as part of a teamMinimum 7-10 years of professional Regulatory affairs experience; with most time in a food or food ingredient company or pharmaceutical company with experiences on nutraceutical products.Good English speaking and writing.Knowledge of food regulations - Stays up-to-date and ensures compliance with laws and regulations.Knowledge in registration/product approval/proprietary approval process knows the type of information and documents to be generated for registration of products.Candidates having knowledge of global regulatory landscape related to probiotics and nutraceutical products and hands on experience - India, Bangladesh, Sri Lanka region will be preferred.Should be able to review & interpret the requirement as per country specific guidelines.Should be able to communicate with relevant functions for procurement of required regulatory documents.Should be able to communicate with relevant counter part at countryQualification:M.Sc in Biotechnology/Food Science, Food technology, Chemistry or related fieldI am interested in this positi

Keyskills :
powerpointmicrosoft officemicrosoft wordexcel

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