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Manager Artwork

2.00 to 5.00 Years   Mumbai City   19 Dec, 2021
Piramal Glass
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryManufacturing
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

* Job Title: Regulatory Affairs Artwork ManagerBusiness Unit: Critical CareBand/Grade:2ALocation:KurlaLast updated on:Sep 2021Department; Group: Regulatory AffairsDegree of Travel required to:Low Purpose of JobThe role is responsible for all artworks for labeling components of Piramal Critical Care Products Worldwide to ensure compliance with innovator labeling, internal company, external partners, regulatory and serialization standards and requirements. Ensure that all artworks are completed accurately and timely in compliance with specific requirements for markets Globally.Key stakeholdersExternalInternalHealth Authority (HA), Country Distributors, CMOs, external partners Cross-Functional: Sales, Marketing, Manufacturing Sites, Supply Chain, Medical Affairs, Quality Assurance, Pharmacovigilance, Planning, Program Management, Packaging Development, Senior Management Reporting structureRole directly reports toPositions that report into this roleRegulatory Compliance Manager, Regulatory Affairs2 ExecutivesEssential Qualifications- BS / MS / B Pharm degree in a science or related field (advanced degree)- Must possess Knowledge of US, EU and global regulatory labeling requirements.- Minimum 5 years artwork experience. Additionally, must have at least 2 years experience managing direct reports.Essential ExperienceKnowledge of global regulatory labeling requirements (Global experience including US, EU and major Rest of World markets preferred).Experience working with Graphics programs such as Corel Draw.Electronic Labeling Management systems such as Harmony preferred.Job ConditionsThis position is based in the Kurla Corporate office.ValuesKnowledge

  • Expertise we strive for a deeper understanding of our domain
  • Innovation we aspire to do things creatively
Action
  • Entrepreneurship we are empowered to act decisively and create value
  • Integrity we are consistent in our thoughts, speech and action
Care
  • Trusteeship we protect the interests of our customers, community, employees, partners and shareholders
  • Humility we aspire to be the best, yet strive to be humble
Key Roles/Responsibilities:
  • Coordinate with external graphic arts organizations for creation of new or revised artworks as per provided annotations. Artworks may be created for commercial or submission purposes.
  • Uploading of new/revised labeling in the Harmony artwork management system. System review as per approved labeling requirements for the indicated market and entry of Health Authority and/or distributor approval of artworks.
  • Responsible for proofreading all types of label copy, annotation, etc. at all development stages as well as final label copy to ensure accuracy and compliance of artworks.
  • Assign and manage workload for team members.
  • Creation and revision of SOPs and/or SWIs for artwork creation processes.
  • Working with team members and Material management, request new Finished good codes and commodity numbers in SAP for materials.
  • Prepare change control documents for labeling and artwork documentation.
  • Providing artwork to internal customers (i.e.- sales) in support of tender submissions or promotional purposes.
, *BS / MS / B Pharm degree in a science or related field (advanced degree)- Must possess Knowledge of US, EU and global regulatory labeling requirements- Minimum 5 years artwork experience. Additionally, must have at least 2 years experience managing direct reports

Keyskills :
supply chaincritical carechange controlmedical affairsquality assurancesenior managementregulatory affairsprogram management

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