Associate, Regulatory Affairs by TipTopJob

TipTopJob (June-2013 से पंजीकृत) ने 12 दिन पहले इस नौकरी को पोस्ट किया था

Relocation Assistance Offered Within Country
Job Number163734 : 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 values-Caring, Inclusive, and Courageous-we foster a culture that inspires our people to achieve common goals. Together, lets build a brighter, healthier future for all.
Job Summary
This position will handle and maintain product compliance during the whole life:cycle, for any category of products. This position will report to the Team Lead, Regulatory Operations.
What you will do
:
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 important metrics, particularly in terms of timelines, status of encouraging 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, European, and third party business partners to acquire the relevant documents and information for product dossiers.
:
Assist in the preparation of Regulatory Standard Operation Procedures, and in keeping track of revision dates.
:
Handle the distribution lists of SOP and the archiving in the documentation system.
:
Artwork Approval:
:
Assist the Regional Regulatory Affairs managers in the preparation and review of list of ingredients for labeling purposes (eg. 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 follows local/regional regulatory requirements, commitments and agreements.
:
Supervise Proficient Authority websites and databases for news related to new product registrations and parallel imports from competition.
:
Assist Regional Regulatory team to deliver and handle Regulatory Assessment
Required Qualifications
:
BS degree in Pharmacy or Life Sciences or relevant education.
:
1 years of experience in regulatory affairs, quality or product development in the pharmaceutical, medical devices or similar FMCG industries.
:
Understanding of registration and regulatory requirements in Europe and North America.
:
Knowledge of industry practices, techniques and standards.
:
Excellent digital literacy, which includes
Job Type: Permanent