Associate, Regulatory Affairs
Associate, Regulatory Affairs
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Job Description
Relocation Assistance Offered Within Country
Job Number#169009 - Mumbai Maharashtra India
Who We Are
Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care Personal Care Home Care Skin Care and Pet Nutrition. Our products are trusted in more households than any other brand in the world making us a household name!
Join Colgate-Palmolive a caring innovative growth company reimagining a healthier future for people their pets and our planet. Guided by our core valuesCaring Inclusive and Courageouswe foster a culture that inspires our people to achieve common goals. Together lets build a brighter healthier future for all.
Brief introduction - Role Summary/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 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.
Artwork Approval:
Assist the Regional Regulatory Affairs managers in the review of list of ingredients for labeling purposes (e.g. INCI and INDI).
Assist the Regional Regulatory Affairs managers with artwork review and approval
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
Required Qualifications :
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.
Preferred Qualifications:
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.
#CPIL #LI-AP1
Our Commitment to Inclusion
Our journey begins with our peopledeveloping strong talent with diverse backgrounds and perspectives to best serve our consumers around the world and fostering an inclusive environment where everyone feels a true sense of belonging. We are dedicated to ensuring that each individual can be their authentic self is treated with respect and is empowered by leadership to contribute meaningfully to our business.
Equal Opportunity Employer
Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion gender gender identity sexual orientation national origin ethnicity age disability marital status veteran status (United States positions) or any other characteristic protected by law.
Reasonable accommodation during the application process is available for persons with disabilities. Please complete this request form should you require accommodation.
#LI-Hybrid
Required Experience:
IC
Employment Type
Full Time
