Regulatory Affairs Associate

  Regulatory Affairs

Job title: Regulatory Affairs Associate

Company: Colgate-Palmolive

Job description: Relocation Assistance Offered Within Country
# 134902 – Mumbai, Maharashtra, India

Job Purpose:

This position will manage and maintain product compliance during the whole life-cycle, for any category of products. This position will report to the Team Lead, Regulatory Operations.

Key Responsibilities:

  • 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 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 eg cosmetics, home care, consumer goods.
  • Work closely with Global, European, and third party business partners 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.
  • Manage the distribution lists of SOP and the archiving in the documentation system.

Artwork Approval:

  • Assist the Regional Regulatory Affairs managers in the 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 compliant with local/regional regulatory requirements, commitments and agreements.
  • 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.
  • At least 1-3 years 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 Africa Eurasian and Asia Pacific countries.
  • Knowledge of industry practices, techniques and standards.
  • Excellent computer skills, which includes working with Google Suite, electronic databases, eCTD software, MS Office applications, Adobe Acrobat Standard or Professional, SAP, DMS, and Authority Regulatory databases and portals for managing changes and submissions.
  • 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. Fluency in spoken and written French and other languages is advantageous.

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.

Are you interested in working for Colgate-Palmolive? You can apply online and attach all relevant documents such as a cover letter and resume or CV. Applications received by e-mail are not considered in the selection process. Become part of our team. We look forward to your application.

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.

For more information about Colgate’s global business, visit the Company’s web site at . To learn more about Colgate Bright Smiles, Bright Futures® oral health education program, please visit . To learn more about Hill’s and the Hill’s Food, Shelter & Love program please visit . To learn more about Tom’s of Maine please visit .

Reasonable accommodation during the application process is available for persons with disabilities. Please contact Application_Accommodation@colpal.com with the subject “Accommodation Request” should you require accommodation.

Expected salary:

Location: Mumbai, Maharashtra

Job date: Sun, 10 Jul 2022 00:37:22 GMT

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