**Job Title: Assistant Manager/Artwork Coordinator** **Job Type: Permanent/Full-Time** **Job Location: Colombia - Remote** **MINIMUM EDUCATION QUALIFICATION**: Bachelor’s/Master’s in Pharmacy/Pharma or other associated scientific discipline **KEY RESPONSIBILITIES**: - Own and drive the artwork initiation and approval processes for all new products, changes / updates to existing products of pharmaceuticals and medical devices products - Plan and initiate the artwork requests on time, coordination with other internal stakeholders, managing the artwork review and approvals, including mockup and production workflows for pharmaceuticals, consumers, medical devices products. - Responsible for initiating any artwork creation or change as a result of Regulatory Affairs (RA) procedure or any other country-initiated request for change of artwork or technical artwork changes based on the information provided by the Technical. - Acts as project owner of all Workflow Requests - can place Workflow Requests on "hold" or request cancellation when necessary. - Responsible for providing Regulatory content, information, and documentation. - Ensures that all applicable fields in the Component Request Details within RA responsibility are populated. **RESPONSIBLE FOR REGULATORY COMPLIANCE, IN PARTICULAR**: - Conformity with the Marketing Authorization. - Consistency with the text approved by the competent Agency, - Selection of the correct style (layout or branding), in order to be compliant with Agency approved layouts for all components. - Consistency of all Packaging Components including package leaflet with the Summary of Product - Characteristics/Physician Circular (if applicable). - Compliance with applicable legislation and guidelines (as locally/regionally relevant), including readability requirements (e.g., font size, line spacing). **RESPONSIBLE FOR ACCURACY OF COUNTRY SPECIFIC DATA SUCH AS**: - information on price, serialization data/format, reimbursement conditions, legal status, - identification and authenticity including commercial barcodes, symbols or pictograms, implementation date for artwork, the relation between artwork changes of several components with their consistency. - ??Responsible for securing a 2nd person review of uploaded files and of the Component Request Details in Artwork Management System (AMS). - Develop and manage working relationships with internal/ external business stakeholders and client groups. - Liaise with Graphic Project Leaders, Packaging, print vendors, customers, and Coordinators to identify and resolve graphic issues including formats, layouts and templates. - Development of tools (i.e., checklists, training guides) to allow for personal growth/development, cross-training of the team, and improve efficiency. **SKILLS REQUIRED**: - At least 5 plus years of experience in Regulatory - Artwork and Labeling, with experience managing artwork changes including mock-up and production, initiating, routing, coordination, and review and approval of artwork changes. - Understanding of pharma packaging/artwork requirements and regulations. - Familiarity with Artwork management systems. Experience of Product Life Cycle Management Tools or Artwork Workflow Management Tool. - Ability to work under deadlines and fast paced work environment. - Ability to work independently with little or no supervision. - Excellent business collaboration/interpersonal skills. - Computer literacy required in Microsoft Office Products such as Word, Excel, and Outlook. - Attention to detail and strong project management skills. - Ability to multitask and prioritize competing agendas. - Good organizational skills. - Language expertise in European, South American or APAC languages like French, German, Italian, Portuguese, Spanish, Chinese, Japanese etc. is a good to have skill, but not mandatory. **Experience**: - Regulatory - Artwork and Labeling: 3 years (required) - Understanding of pharma packaging/artwork: 3 years (required)