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
Product Registration and Life cycle management
• 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 Regional Regulatory Affairs Department with relevant important metrics, 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.
• Assist the Regional Regulatory Affairs Department in preparing submissions to Competent Authorities and Notified Bodies, ensuring timely approval of new products and life-cycle submissions.
• Keep track of outstanding documentation and notify the relevant Regional Regulatory Affairs manager in a timely manner.
• Alert Regional Regulatory Affairs manager of upcoming renewals and commitments in a timely manner.
• Assist in the electronic submission of product dossiers, variations and responses to Competent Authorities.
• Update and maintain product registration and ingredients archives, databases and tracking tools.
• Upload and publish electronic Common Technical Document (eCTD) sequences for medicinal products.
• Upload and maintain technical files/dossier databases for medical devices and biocides.
• 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 European functions to acquire the relevant documents and information for product dossiers.
• Assist in the preparation of Regulatory Standard Operation Procedures, and in keeping track of revision dates.
• Handle the distribution lists of SOP and the archiving in the documentation system (DMS).
• Ensure accurate electronic archiving of all documents submitted to and received from Competent Authorities and Notified Bodies, as well as accurate and timely data update of regulatory compliance databases and tools for assigned products.
Artwork Approval and INCI Creation :
• Assist the Regional Regulatory Affairs managers in the review of list of ingredients for labeling purposes (eg. INCI and INDI).
• Assist the RA managers with artwork review and approval
• Assist with the preparation of International Nomenclature of Cosmetic Ingredients (INCI)
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 aligned with local/regional regulatory requirements, commitments and agreements.
• Track Competent Authority websites and databases for news related to new product registrations and parallel imports from competition.
Regulatory Assessments :
• Assist Regional Regulatory team to deliver and handle RA assessment, regulatory training and contribute to the training plan and modules. Also assist deliver regulatory assessments in regulatory due diligences.
• Ensure participation in key meetings for the regulatory function and provide timely feedback.
• 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 European countries.
• Knowledge of industry practices, techniques and standards.
• Excellent computer skills, which includes working with electronic databases, eCTD software, MS Office applications (working with templates, and editing and formatting complex documents), Adobe Acrobat Standard or Professional, Internet and Intranet, Google Suite, 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.
• Ability to work and meet tight deadlines.
• Proficiency in spoken and written English. Knowledge of French or German language is advantageous.
Experience : 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 : 15th August, 2021
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