The Training and Development effort at Colgate-Palmolive is a direct outcome of the Individual Development Plan and the Business need. The business critical and individual specific needs are identified every year and a training needs inventory is drawn up.
Colgate's leadership position in the global marketplace is directly linked to the skill of our employees. Practical learning and professional growth are critical to our continued success. We invest generously in the training and education of Colgate people.
Post : Sr. Associate - Regulatory Affairs
Job Responsibilities:
- Collaborate with Regulatory Affairs (RA) Managers on programs and activities within all regions to align on priorities and product registrations.
- Manage RA Associates supporting roles by coordinating the efforts of the operational regulatory team based in India.
- Manage global registration database and prepare documentation for registrations required for products manufactured in North America 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.
- Maintain and update 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, annual registrations and maintenance of product registration dossiers for authorities.
- Upload and publish electronic Common Technical Document (eCTD) sequences for drug and medicinal products for select regions.
- Ensure Regulatory Assessments are completed in a timely manner.
- Assist RA Regions with artwork approvals.
- Manage preparation of core dossiers for multiple region filings to be modified for submission as needed at the regional level.
- Ensure content, organization and overall quality of all regulatory documents and samples are adequate and complies with local/regional regulatory requirements, commitments and agreements.
- Manage dossier and document storage for country registrations for easy reference.
- 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
Candidate Profile
BS degree in Pharmacy or Life Sciences or relevant education. Advanced degree preferred
EXPERIENCE:
- At least 3-5 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.
- Knowledge of industry practices, techniques and standards.
- Knowledge/understanding/experience in the following legislations and field would be an added value
- Cosmetics/Home Care
- Medical Devices/Medicinal Productss/Complimentary Medicine
- Disinfectants
Additional Information:
Experience: 3-5 years
Location: Mumbai
Qualification: Degree in Pharmacy or Life Sciences
Functional Area: R&D
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