Regulatory Associate @ Colgate-Palmolive Company Bachelor’s degree in Pharmacy or Life Sciences or relevant education
Who
We Are
Colgate-Palmolive Company is a global consumer products company operating in
over 200 countries specialising 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
values—Caring, Inclusive, and Courageous—we foster a culture that inspires our
people to achieve common goals. Together, let's build a brighter, healthier
future for all.
Brief introduction - Role
Summary/Purpose
This position is responsible for assisting with the
regulatory affairs activities of India Extended Hub, providing support for
product registrations and maintenance of product compliance throughout the
whole life-cycle for cosmetics, medical devices, home care products, medicinal
products and also for any other category of products, for this
region. This position will report to the Regulatory Affairs Lead, India
Extended Hub.
Responsibilities
Support
India Extended Hub Regulatory Affairs programs and activities for new product
registration and life-cycle management of CP portfolio, including but not
limited to, product registration renewals, variations, notifications and/or new
license applications.
- Assist
in the implementation of the regulatory strategy defined at Regional
and/or Global level, and report regularly the progress to India Extended
Hub Regulatory Affairs Lead with relevant KPIs, particularly in terms of
timelines, status of supportive data required from other functions and
dossier preparation.
- Work
closely with the Global Regulatory Operation team to 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
in preparing submissions to Competent Authorities, for timely approval of
new products and life-cycle submissions.
- Track
outstanding documentation and notify the India Extended Hub Regulatory
Affairs Lead in a timely manner.
- Inform
India Extended Hub Regulatory Affairs Lead 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 maintain technical files/dossier databases for the products.
- Assist
in the preparation of Regulatory Standard Operation Procedures, and in
keeping track of revision dates.
- Ensure
proper electronic archiving of all documents submitted to and received
from Competent Authorities, as well as accurate and timely data update of
regulatory compliance databases and tools for assigned products.
- Assist
with artwork review and approval as instructed by the direct manager.
- Understand
current regulations, guidelines and standards relevant to ensure
compliance to the applicable regulatory and corporate
standards/requirements (cosmetics, medical devices, medicinal products,
home care products, etc.)
- 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 regulatory
developments.
- Assist
India Extended Hub Regulatory team to deliver and manage RA
assessments.
- Assist
India Extended Hub Regulatory team to deliver Regulatory training and
contribute to the Regulatory training plan and modules.
- Collaborate
closely with the Regulatory Operations team to ensure timely and accurate
execution of assigned tasks.
- Ensure
participation in key meetings for the regulatory function and provide
timely feedback.
Required
Qualifications
- Minimum,
Bachelor’s degree in Pharmacy or Life Sciences or relevant
education.
- At
least 3 years of relevant experience in regulatory affairs, quality or
product development in pharmaceutical, medical devices or similar FMCG/CPG
companies.
- Understanding
of/exposure to the registration and regulatory requirements in India.
Knowledge of the requirements of other countries in the hub will be an
added advantage.
- 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.
Preferred
Qualifications
- Good
written and verbal communicator with excellent interpersonal skills.
- Good
planning and organizing skills.
- Fluency
in spoken and written English.
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