Associate – Regulatory Affairs | Recruitment | Colgate Palmolive
About Company
We are Colgate, a caring, innovative growth company reimagining a healthier future for all people, their pets, and our planet. The soap and candle business that William Colgate began in New York City early in the 19th century is now, more than 210 years later, a global consumer goods company with more than 34,000 employees serving hundreds of millions of people around the globe with a brand found in more homes than any other in the world.
Our history and continuous innovations underscore the perpetual strength and creativity of our people around the world. We are always thinking about how we can improve our world and what we can do better. Focused on Oral Care, Personal Care, Home Care and Pet Nutrition and reaching more than 200 countries and territories, Colgate teams develop, produce, distribute and sell health and hygiene products and pet nutrition essential to society.
Our brands include Colgate, Palmolive, elmex, meridol, Tom’s of Maine, hello, Sorriso, Speed Stick, Softsoap, Irish Spring, Protex, Sanex, Filorga, eltaMD, PCA Skin, Ajax, Axion, Fabuloso, Soupline and Suavitel, as well as Hill’s Science Diet and Hill’s Prescription Diet. These are among the world’s most recognizable household names, trusted and relied upon by consumers everywhere.
“A caring, innovative growth company reimagining a healthier future for all people, their pets, and our planet.“
Colgate people are as diverse as the people we serve around the world. We come from many different countries, with unique backgrounds, characteristics and skill sets. Our diversity makes us stronger in every way. And while we celebrate and encourage individual expression and personal accountability, we also have many traits in common across Colgate.
First and foremost, we share a commitment to our three core values: Caring, Global Teamwork and Continuous Improvement. These values are reflected not only in the quality of our products and the reputation of our Company, but also in our ambition to build a future to smile about. They represent who we are and how we work.
We also like to talk about our culture in terms of how we F.E.E.D. the growth. We are Focused on our purpose and strategic priorities, recognizing that while we can do anything, we cannot do everything. We are Empowered. Colgate people are encouraged and resourced to contribute and make decisions as close to where we execute as possible.
We are Experimental to accelerate innovation and learning, not afraid to take risks and eager to expand our skills. And we are Digital, a connected and data-driven company that values intelligence and technology to better serve our world.
If you remember one thing from this letter, let it be where it began – with our purpose. Colgate People are committed to reimagining a healthier and more sustainable future for all. As a public company, we want to achieve long-term, sustainable growth for all of our stakeholders.
As an organization that relies on the ingenuity of our people to succeed, we work hard to offer a best place to work where our people feel they belong and want to grow. As a packaged goods company, we will always strive to earn the trust and preference of our customers and consumers. As the one and only Colgate-Palmolive Company, we can – and we will – build a healthier, more sustainable future for all.
We are pleased that you are interested to learn more about the Colgate-Palmolive Company. We have many stories to share and hope you will take a few minutes to read about our extraordinary people, our purpose and our products.
Job Description
We are looking for Associate – Regulatory Affairs to join our team at our Global Technology Centre in Mumbai. Reporting to Team Lead – North America, EU & APAC, you will be accountable for assisting with the regulatory operational activities of global development programs, providing regulatory support for worldwide registrations. Also maintenance of products throughout the life-cycle primarily for medicinal products and medical devices, and any other category of products, for the European Division.
Regulatory Assessments:
Assist Regional Regulatory team to deliver and handle RA assessment, deliver Regulatory training and contribute to the Regulatory training plan and modules & assist in regulatory assessments in regulatory due diligences. Also, ensure participation in key meetings for the regulatory function and provide timely feedback.
Functional Linkages:
Internal clients and partners such as the Regulatory Affairs Team in the EU region, Department/Section Managers, Professional and Technical staff. Also, Peers in other Functions (Primarily Regulatory and Technology team but may also include other functions such as Quality, Marketing in the client locations)
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Responsibilities
- Work closely and support Regional Regulatory Affairs programs and activities for new product registration and life-cycle management of CP portfolio. Including and 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 RA Department with relevant important metrics. Particularly in terms of timelines, status of encouraging data required from other functions and dossier preparation.
- Compile documents and data required for high quality and successful submissions, license renewals and annual registrations, and maintenance of product registration dossiers for authorities.
- Work with the Regional Department in preparing submissions to Proficient Authorities and Notified Bodies, ensuring timely approval of new products and life-cycle submissions.
- Notify Regional Manager of upcoming renewals and commitments promptly and inform the tracking of outstanding documentation.
- Upload and publish electronic Common Technical Document (eCTD) sequences for medicinal products. Work closely with Global and European functions 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 (DMS).
- Ensure accurate electronic archiving of all documents submitted to and received from Proficient Authorities and Notified Bodies. As well as accurate and timely data update of regulatory compliance databases and tool for assigned products.
- Assist the Regional RA Managers in the review of list of ingredients for labelling purposes (eg. INCI and INDI), & also assist them with artwork review and approval.
- Track Proficient Authority websites and databases for news related to new product registrations and parallel imports from competition.
Qualifications
- Bachelor’s degree in Pharmacy or Life Sciences or relevant education. Advanced degree preferred. Minimum 1 yr. of working 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, experience with medicinal products and devices is an added advantage.
- Excellent digital literacy, working with electronic databases, eCTD software, MS Office applications. Also, Adobe Acrobat Standard or Professional, Google Suite, SAP, DMS, and Authority Regulatory databases and portals for handling changes and submissions.
- Excellent interpersonal skills, good planning and organizing skills, ability to work under stress and meet timelines. Proficiency in spoken and written English. Additional language expertise such as French or German is an advantage.