Jobs in India

Job Title : Associate Regulatory Affairs

Job Location : Maharashtra

Job Location Type : Hybrid

Job Contract Type : Fulltime

Job Seniority Level :

Job Number #163641 Mumbai Maharashtra India

Who We Are

ColgatePalmolive 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 ColgatePalmolive 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 let's build a brighter healthier future for all.

Job Summary

This position will handle and maintain product compliance during the whole lifecycle 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 lifecycle 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 critical 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 the need arises 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

Preferred Qualifications

CPIL

Compensation And Benefits

Salary Range $ $ USD

Pay is determined based on experience qualifications and location. Salaried employees may also be eligible for discretionary bonuses profitsharing and longterm incentives for Executivelevel roles.

Benefits : Salaried employees enjoy a comprehensive benefits package including medical dental vision basic life insurance paid parental leave disability coverage and participation in the 401(k) retirement plan with company matching contributions subject to eligibility requirements. Additional benefits include a minimum of 15 vacation / PTO days (hourly employees receive a minimum of 120 hours) and 13 paid holidays (vacation days are prorated based on the employee's hire date within the calendar year). Paid sick leave is adjusted based on role and location in accordance with local laws. Detailed information regarding paid sick leave entitlements will be provided to employees upon hiring and may be subject to adjustments based on changes in legislation or company policies.

Our Commitment to Diversity Equity & Inclusion

Achieving our purpose starts with our people — ensuring our workforce represents the people and communities we serve —and creating an environment where our people feel they belong; where we can be our authentic selves feel treated with respect and have the support of leadership to impact the business in a meaningful way.

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.

Reasonable accommodation during the application process is available for persons with disabilities. Please complete this request form should you require accommodation.

For additional Colgate terms and conditions please click here.

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Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full Time

Vacancy : 1