
Associate - Regulatory Affairs
7 days ago
Relocation Assistance Offered Within Country
145192 - Mumbai, Maharashtra, India
**About Colgate-Palmolive**
Do you want to come to work with a smile and leave with one as well? In between those smiles, your day consists of connecting with others across the world, full of stimulating discussions, and making impactful contributions
If this is how you see your career, Colgate is the place to be
Our dependable household brands, dedicated employees, and sustainability commitments make us a company passionate about building a future to smile about for our employees, consumers, and surrounding communities. We win as a global organization by continually learning and collaborating. The pride in our brand fuels a workplace that encourages creative thinking, champions experimentation, and promotes authenticity which has contributed to our enduring success. If you want to work for a company that lives by their values, then give your career a reason to smile...every single day.
This position will manage and maintain product compliance during the whole life-cycle, for any category of products, specifically for products marketed in Asia Pacific. This position will report to the Team Lead, Regulatory Operations.
**Key Responsibilities**:
- Support the regulatory strategy defined at Regional and/or Global level, and report regularly the progress to the Regional Regulatory Affairs Department with relevant KPIs, particularly in terms of timelines, status of supportive 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 e.g. cosmetics, home care, consumer goods.
- Work closely with Asia Pacific and Global business partners to obtain the relevant documents and information for Product Dossiers, Product Information Files, and Special Certifications (i.e. - Halal Certifications)
**Artwork Approval**:
- Assist the Regional Regulatory Affairs managers in the creation and review of list of ingredients for labelling purposes (e.g. 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 (cosmetic products, drug products, medical devices, etc.).
- Track Competent Authority websites and databases for news related to new product registrations and parallel imports from competition.
- Assist Regional Regulatory team to deliver and manage Regulatory Assessment
**Requirements**:
- BS degree in Pharmacy or Life Sciences or relevant education. Advanced degree preferred.
- Minimum 1 year of relevant experience in regulatory affairs, quality or product development in the pharmaceutical, medical devices or similar FMCG industries.
- Understanding of registration and regulatory requirements in Asia Pacific countries.
- Knowledge of industry practices, techniques and standards.
- Good written and verbal communicator with excellent interpersonal skills.
- Good planning and organizing skills.
- Ability to work under stress and meet deadlines.
- Fluency in spoken and written English is mandatory.
Equal Opportunity Employer
Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law.
Colgate-Palmolive is a leading global consumer products company, tightly focused on Oral Care, Personal Care, Home Care and Pet Nutrition. Colgate sells its products in over 200 countries and territories around the world under such internationally recognized brand names as Colgate, Palmolive, elmex, Tom’s of Maine, Sorriso, Speed Stick, Lady Speed Stick, Softsoap, Irish Spring, Protex, Sanex, Elta MD, PCA Skin, Ajax, Axion, Fabuloso, Soupline and Suavitel, as well as Hill’s Science Diet and Hill’s Prescription Diet.
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