Established in 1806 as a small soap and candle business in New York City, Colgate-Palmolive is now a truly global company with products sold in over 200 countries and territories under such internationally recognized brand names as Colgate, Palmolive, Softsoap, Irish Spring, Protex, Sorriso, Kolynos, elmex, Tom's of Maine, Sanex, Ajax, Axion, Soupline, Haci Sakir, Suavitel, PCA SKIN, EltaMD, Filorga and Hello as well as Hill's Science Diet and Hill's Prescription Diet.
Post : Associate, Regulatory Affairs
Job Description
Purpose : This position will manage and maintain product compliance during the whole life-cycle, for any category of products. This position will report to the Team Lead, Regulatory Operations.Engage proactively with diverse cross-functional teams, including R&D, legal, regulatory, and marketing departments, to meticulously develop and rigorously review all ingredient lists. This collaborative effort is crucial to guarantee the utmost accuracy and comprehensiveness of each list, ensuring full compliance with all relevant regulations and internal company standards. The objective is to achieve complete alignment across all stakeholders, from initial concept to final product launch, preventing discrepancies and ensuring transparency.
Responsibilities
• Responsible for developing/reviewing accurate and comprehensive ingredient lists while collaborating closely with cross-functional stakeholders to ensure alignment and timely updates. Manage and maintain a detailed tracking system to monitor ingredient list status, changes and requirements, facilitating smooth communication and efficient project progress.
• 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 KPIs, particularly in terms of timelines, status of supportive 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.
• Keep track of outstanding documentation and open queries from Authorities, and notify the relevant Regional Regulatory Affairs manager in a timely manner.
• Update and maintain product registration and ingredients archives, databases and tracking tools.
• Upload and maintain as required by the Regional RA team any documentation supporting the placing of the market of other categories of products eg cosmetics, home care, consumer goods.
• Work closely with Global and third party business partners to obtain the relevant documents and information for product dossiers.
• Assist in the preparation of Regulatory Standard Operation Procedures, and in keeping track of revision dates.
• Manage the distribution lists of SOP and the archiving in the documentation system.
Regulatory intelligence and product advocacy activities :
• Understand current regulations, guidelines and standards relevant to ensure compliance to the applicable regulatory and corporate standards/requirements (medicinal products, medical devices, cosmetic products, biocides, detergents, consumer goods).
• Ensure that the content, organization and overall quality of all regulatory documents are adequate and compliant with local/regional regulatory requirements, commitments and agreements.
• Track Competent Authority websites and databases for news related to new product registrations.
• Assist Regional Regulatory team to deliver and manage Regulatory Assessment
Candidate Profile
• BS degree in Pharmacy or Life Sciences or relevant education. Advanced degree preferred.
• Minimum 1 year of relevant experience in regulatory affairs, quality or product development in the pharmaceutical, medical devices or similar FMCG industries.
• Understanding of registration and regulatory requirements in Africa Eurasian and Asia Pacific countries.
• Knowledge of industry practices, techniques and standards.
• Excellent computer skills, 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 managing changes and submissions.
• Good written and verbal communicator with excellent interpersonal skills.
• Good planning and organizing skills.
• Ability to work under stress and meet deadlines.
• Fluency in spoken and written English is mandatory.
• Fluency in languages is advantageous.
Additional Information
Experience : Minimum 1 year
Qualification : BS degree in Pharmacy or Life Sciences
Location : Mumbai, Maharashtra
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 10th October 2025
See All Mumbai Alerts B.Pharm Alerts M.Pharm Alerts
See All Other Jobs in our Database
Subscribe to Pharmatutor Job Alerts by Email
