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Regulatory Affairs Associate require at Colgate-Palmolive | B.Pharm apply


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Regulatory Affairs Associate require at Colgate-Palmolive

Colgate-Palmolive is a leading global consumer products company, tightly focused on Oral Care, Personal Care, Home Care and Pet Nutrition. Colgate sells its products in over 200 countries and territories around the world under such internationally recognized brand names as Colgate, Palmolive, elmex, Tom’s of Maine, Sorriso, Speed Stick, Lady Speed Stick, Softsoap, Irish Spring, Protex, Sanex, Elta MD, PCA Skin, Ajax, Axion, Fabuloso, Soupline and Suavitel, as well as Hill’s Science Diet and Hill’s Prescription Diet.

Post : Associate - Regulatory Affairs

Job Description
Job Purpose
This position will handle and maintain product compliance during the whole life-cycle, for any category of products, specifically for products marketed in the USA and Canada. This position will report to the Team Lead, Regulatory Operations.

Key Responsibilities
• Work closely with and support the Regional Regulatory Affairs Department in new product registration and life-cycle management of CP portfolio, including but not limited to, product renewals, variations, notifications and/or new license applications.
• Support the regulatory strategy defined at Regional and/or Global level, and report regularly the progress to the Regional Regulatory Affairs Department with relevant important metrics, particularly in terms of timelines, status of encouraging data required from other functions and dossier preparation.
• Compile documents and information required for high quality and successful submissions, license renewals and annual registrations, and maintenance of product registration dossiers for Authorities and Notified Bodies.
• Provide support for State and EPA registrations per US requirements, Drug and Device annual establishment registrations, and Voluntary Cosmetic Registration Program activities.
• Assist in the preparation of Regulatory Standard Operation Procedures, and in keeping track of revision dates.
• Assist in preparing core dossiers for multiple region filings to be modified for submission as needed at the regional level.
• Forward regulatory bundle to the country authority or external consultant/external lab/ partnership (where applicable).
• Update and maintain product registration and ingredients archives, databases and tracking tools.
• Assist with artwork approval with regards to confirmation of INCI lists, registration numbers, review of product labeling and promotional material to ensure compliance with proof of claims.
• Stay ahead of updates and changes with International Standards related to products and processes to ensure compliance.

Candidate Profile
• BS degree in Pharmacy or Life Sciences or relevant education. Advanced degree preferred.
• At least 1-3 years of validated experience in regulatory affairs, quality or product development in the pharmaceutical, medical devices or similar FMCG industries.
• Understanding of registration and regulatory requirements in the USA (federal and state) and Canada.
• Knowledge of industry practices, techniques and standards.
• Excellent digital literacy, which includes working with Google Suite, electronic databases, eCTD software, MS Office applications, Adobe Acrobat Standard or Professional, SAP, DMS, and Authority Regulatory databases and portals for handling changes and submissions.
• Good written and verbal communicator with excellent interpersonal skills.
• Good planning and organizing skills.
• Good excellent teammate and collaborative.
• Ability to work under tight deadlines and meet timelines.
• Proficiency in spoken and written English is mandatory.

Additional Information
Experience : 1-3 years
Qualification : Bachelor’s degree in Pharmacy or Life Sciences
Location : Mumbai, Maharashtra
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 20th June, 2022


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