Global Regulatory Labelling – Senior Associate

Job Description:

  • The point person for business units in developing packaging and labeling strategies, project plans and executing project plans.
  •  Responsible for the packaging and labelling of food, nutraceuticals, herbals and supplements products in accordance with regulations.
  •  You will develop the information printed on the outward packaging and inner leaflet, which contains important safety information and any adverse effects.
  • The artwork aspect of these roles ensures that the packaging adheres to the company’s brand guidelines.
  • Liase with artwork team to develop artwork.
  • Authoring and managing patient information leaflets (PILs) and summary of product characteristics (SmPCs) and other documents (CCDS etc).
  • Responsible for updating label information according to health authorities, reviewing documentation and updating the company’s core data sheet, which contains information on every product developed by the company.
  • Participate in labelling committee meeting
  • Development, improve, and implement labelling processes.
  • Provide strategic advice for the development of labelling activities
  • Communicate with stakeholders & regulatory authorities on complex labelling concept
  • Ensure stakeholders understand outputs of all decisions and track project status and maintain product label and package design and process knowledge for those platforms responsible.
  • Represent Packaging and Labeling in Change Review Board (CRB) within design change control process and is accountable for executing Design Change documentation.

Required Qualification: Minimum of a bachelor’s degree in a Scientific or Life Science’s Discipline
Required Experience:

  • EU market experience
  • 4+ years Regulatory Affairs experience focusing on Labelling activities
  • Project management experience
  • Experience developing, implementing and operating labelling processes

Job Position code: JD-PEP-FRL-16-001
Job Title: Global Regulatory Labelling – Senior Associate
Department: Digital Marketing
Reports To: Team Lead

Job Purpose:
In this role, you will be responsible for managing all global and regional labelling activities for markets products and will play an important role in providing strategic advice for developing products.
Work Schedule:
Full Time, Monday to Saturday, 8:00a.m. to 5:00pm. Hours may vary on occasion, depending on workload.

Skills Required:

  • Different skills will be required of labeling specialists depending on the industry they are working in, but knowledge of current FDA, USDA, EU, labeling regulations and global product labeling regulations will be standard.
  •   A labeling specialist will create product labels and maintain databases of labels, ingredients, and formulas; therefore, a strong attention to detail and efficiency in proofreading, data entry, and database management is essential. Adherence of good manufacturing practice (GMP), quality, and safety practices will also be required.
  •   Labeling specialists not only interact with regulatory affairs teammates but also cross-functionally with clinical, medical, legal, safety, commercial, quality, and supply chain associates, so they must have excellent written and verbal communication skills and interpersonal skills.

Reach us:

Human Resource
Mail Id:
Contact Number: 9384806335

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