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, Speed Stick, Lady Speed Stick, Softsoap, Irish Spring, Protex, Sorriso, Kolynos, elmex, Tom’s of Maine, Sanex, Ajax, Axion, Fabuloso, Soupline and Suavitel, as well as Hill’s Science Diet, Hill’s Prescription Diet and Hill’s Ideal Balance.
Post : Global Regulatory Affairs Associate
Job Responsibilities:
- Work closely with and support Regulatory Affairs (RA) programs and activities for North America /Eurasia
- Maintain global registration database and prepare documentation for registrations required for products manufactured in North America/Eurasia and distributed in other regions.
- Support the regulatory strategy defined at Regional and/or Global level, and report regularly the progress to Regional RA Department with relevant KPIs, particularly in terms of timelines, status of supportive data required from other functions and dossier preparation.
- Assist with the maintenance of the master registration tracking tool with existing, new and pending registration information.
- Compile required documents from source countries for high quality and successful submissions, license renewals and annual registrations and maintenance of product registration dossiers for authorities.
- Carry out Global Product Registration requests in e-team room.
- Assist in the preparation and update of 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).
- Follow up closely with the registration progress.
- Archive all documents of each country’s application and manage for easy reference.
- Maintain database with information on regulatory requirements per country (ID card).
- 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.
- Keep abreast of updates and changes with International Standards related to products and processes to ensure compliance. Provide feedback to country specific RA Managers.
- Upload and publish electronic Common Technical Document (eCTD) sequences for medicinal products
Candidate Profile
BS degree required. Advanced degree preferred
EXPERIENCE :
1) At least 1-3 years of relevant experience in regulatory affairs, quality or product development in pharmaceutical, medical devices or similar
2) Fair understanding of registration and regulatory requirements.
3) Knowledge/understanding/experience in the following legislations and field would be an added value
- Cosmetics/Home Care
- Medical Devices/Medicinal Products/Complimentary Medicine
- Disinfectants
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OTHER SKILLS :
* Excellent computer skills which includes working on electronic databases and MS office applications.
* Good written and verbal communicator with excellent interpersonal skills.
* Good planning and organizing skills
* Fluency in spoken and written English. Knowledge of any additional language is advantageous.
Additional Information:
Experience: 1-3 years
Location: Mumbai
Education: BS degree
Industry Type:Pharma/Healthcare/Clinical research
Functional Area: RESEARCH AND DEVELOPMENT
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