When William Colgate established the small soap and candle business in New York City in 1806, he could hardly have imagined what it would become over the next two centuries: a truly global company serving billions of consumers worldwide. But we suspect Mr. Colgate would admire the Colgate People and core values that are still the lifeblood of our success.
Job Description
- Post Name: Associate – Regulatory Affairs
- Qualification: Bachelor’s degree in Pharmacy or Life Sciences or relevant education. Advanced degree preferred!
- Experienced: Minimum 1 year of proven experience in regulatory affairs, quality or product development in pharmaceutical, medical devices or similar FMCG/CPG companies.
- Location: Sanand, Gujarat, India
Main Responsibilities
- Work closely with and support Regional Regulatory Affairs programs and activities for 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 important metrics, particularly in terms of timelines, the 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.
- Assist the Regional Regulatory Affairs Department in preparing submissions to Proficient Authorities and Notified Bodies, ensuring timely approval of new products and life-cycle submissions.
- Track outstanding documentation and advise the relevant Regional Regulatory Affairs Manager in a timely manner.
- Advise Regional Regulatory Affairs Manager of upcoming renewals and commitments in a timely manner. Assist in the electronic submission of product dossiers, variations and responses to Proficient Authorities.
- Update and maintain product registration and ingredients archives, databases and tracking tools. Upload and publish electronic Common Technical Document (eCTD) sequences for medicinal products.
- Upload and maintain technical files/dossier databases for medical devices and biocides, also if required by the Regional RA team any documentation supporting the placing on the market of other categories of products eg cosmetics, home care, consumer goods
- Work closely with Global and European functions to obtain 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 (DMS).
- Ensure accurate electronic archiving of all documents submitted to and received from Competent Authorities and Notified Bodies, as well as accurate and timely data updates of regulatory compliance databases and tools for assigned products.
- Assist the Regional Regulatory Affairs Managers in the review of list of ingredients for labeling purposes (eg. INCI and INDI). Assist the RA Managers with artwork review and approval
- 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 aligned with 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.
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.
- Assist Regional Regulatory team to deliver regulatory assessments in regulatory due diligences.
- Ensure participation in key meetings for the regulatory function and provide timely feedback.
Required (Education, Knowledge required, Language skills, etc)
- Bachelor’s degree in Pharmacy or Life Sciences or relevant education. Advanced degree preferred!
- Minimum 1 year of proven experience in regulatory affairs, quality or product development in pharmaceutical, medical devices or similar FMCG/CPG companies.
- Understanding of registration and regulatory requirements in European countries.
- Knowledge of industry practices, techniques and standards
- Knowledge and experience with medicinal products and medical devices is an advantage.
- Excellent digital literacy, which includes working with electronic databases, eCTD software, MS Office applications (working with templates, and editing and formatting sophisticated 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 communication with excellent interpersonal skills.
- Good planning and organizing skills.
- Ability to work under pressure and meet deadlines.
- Proficiency in spoken and written English. Knowledge of any additional language such as French or German is an advantage.
Preferred Requirements:
- Partnership and collaboration
- Leading Change
- Microsoft Office or Google Suite proficiency (i.e, Sheets, Slides, Docs) preferred
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