Work as Global Regulatory Affairs Associate at Colgate-Palmolive

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 : Global Regulatory Affairs Associate

RESPONSIBILITIES
Product Registration and Lifecycle 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 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
- Alert Regional Regulatory Affairs manager of upcoming renewals and commitments in a timely manner
- Upload and publish electronic Common Technical Document (eCTD) sequences for medicinal products
- Work closely with Global and European functions to obtain the relevant documents and information for product dossiers
- 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

Artwork Approval:
- Assist the Regional Regulatory Affairs managers in the review of list of ingredients for labeling purposes
- Assist the RA 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 and parallel imports from competition

Find more info on Next Page...

Subscribe to Pharmatutor Job Alerts by Email

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
- Ensure participation in key meetings for the regulatory function and provide timely feedback

Candidate Profile
1) BS degree in Pharmacy or Life Sciences or relevant education. Advanced degree preferred
2) 1-3 years of relevant experience in regulatory affairs, quality or product development in the pharmaceutical, medical devices or similar FMCG industries
3) Understanding of registration and regulatory requirements in Africa Eurasian countrie

OTHERS :
- 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 managing changes and submissions
- Good written and verbal communicator with excellent interpersonal skills
- Fluency in spoken and written English. Knowledge of French language is advantageous

Additional Information:
Experience: 1-3 years
Location: Mumbai
Education: Degree in Pharmacy or Life Sciences
Industry Type: Pharma/Healthcare/Clinical research
Functional Area: Regulatory Affairs