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 Purpose:
This position is responsible for assisting with the regulatory operational activities of global development programs, providing regulatory support for worldwide registrations and maintenance of products throughout the whole life-cycle primarily for medicinal products and medical devices, and also for any other category of products, for the European Division. This position will report to the Team Lead – North America/Global.
Key Accountabilities:
• Work closely with and support Regional Regulatory Affairs programs and activities for 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 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.
• 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.
• Track outstanding documentation and notify the relevant Regional Regulatory Affairs Manager in a timely manner.
• Inform 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 on the market of other categories of products eg cosmetics, home care, consumer goods
• Work closely with Global and European functions 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 (DMS).
• Ensure proper 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 tool for assigned products.
• 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
• 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 and parallel imports from competition (UK and Germany).
Regulatory Assessments:
• Assist Regional Regulatory team to deliver and manage RA assessment.
• Assist Regional Regulatory team to deliver Regulatory training and contribute to the Regulatory training plan and modules.
• Assist Regional Regulatory team to deliver regulatory assessments in regulatory due diligences.
• Ensure participation in key meetings for the regulatory function and provide timely feedback.
Candidate Profile
• Bachelor’s degree in Pharmacy or Life Sciences or relevant education. Advanced degree preferred.
• Minimum 2 years of relevant experience in regulatory affairs, quality or product development in pharmaceutical, medical devices or similar FMCG/CPG companies.
• Understanding of registration and regulatory requirements in European countries.
• Knowledge of industry practices, techniques and standards.
• Knowledge and experience with medicinal products and medical devices is an advantage.
• 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 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. Knowledge of any additional language such as French or German is an advantage.
Additional Information
Experience : 2 years
Qualification : B.Pharm, B.Sc ; Advanced degree preferred
Location : Mumbai
Industry Type : Pharma
Functional Area : Regulatory Affairs
End Date : 30th December, 2019
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