Home / Job / Colgate-Palmolive Hiring Associate, Regulatory Affairs B.Sc. , B.Pharm M.Sc./M.Pharm Apply Now

Colgate-Palmolive Hiring Associate, Regulatory Affairs B.Sc. , B.Pharm M.Sc./M.Pharm Apply Now

Colgate-Palmolive Hiring Associate, Regulatory Affairs B.Sc. , B.Pharm M.Sc./M.Pharm Apply Now

As an Associate – Regulatory Affairs you will support the Global Regulatory Affairs Team in terms of documentation and processes involved with the creation of ingredient lists and also to support related activities pertaining to Regulatory product life cycle management.

Key Responsibilities:

To support organizational objectives by undertaking multiple activities, including creating ingredient lists and uploading ingredient lists into the artwork database.

Upload proof of claims and notification of launches in centralized database and notification portal respectively.

Tracking of requests for ingredient list, notifications, and proof of claims. This also involves maintaining record of relevant documents for the activities handled.

Partner with global technology teams and other stakeholders i.e. regulatory, also to create ingredient list and route for approvals in electronic database.

To notify launches on the Europe notification portal.

Serve as custodian for proof of claims of cosmetic products created by project leader from India Global Technology Centre.

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 and status of supportive data required from other functions and dossier preparation.

Keep track of outstanding documentation and notify the relevant Regional Regulatory Affairs manager on a timely manner.

Work closely with Global functions to obtain the relevant documents and information for ingredient list creation and product dossiers.

Assist in the preparation of Regulatory Standard Operation Procedures, and in keeping track of revision dates.

Manage the distribution lists of SOP and the archiving in the documentation system (DMS).

Ensure proper electronic archiving of all documents, as well as accurate and timely data update of regulatory compliance databases and tool for assigned products.

Assist the RA managers with artwork review and approval.

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.

Track Competent Authority websites and databases for news related to ingredient listing, and regulation changes pertaining to Colgate products.

Functional Linkages:

Internal: Department/Section Managers, Professional and Technical staff, Peers in other Functions (Primarily Regulatory and Technology team)   

External: Product Vendors/Suppliers

Experience:

Essential:  Industrial experience in the Fast Moving Consumer Goods industry / Personal Care / Home Care Products or Pharma industry

Desirable: Knowledge of formulations development

No. of years of Experience required: Minimum 1 yr

Essential: B.Sc. , B.Pharm, Pharmaceutics

Desirable: M.Sc./M.Pharm. Knowledge and/or experience in product development.

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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