Artwork change specialist required by leading pharmaceutical company. Long contract available!
Working directly with senior management, this role is offered on an initial 12 month contract with extension beyond. The successful candidate will work with the regulatory and quality departments to monitor the change management process to approve new or revise packaging components in accordance with regulatory timelines.
- Track the approval status of packaging components, in line with the EMA (European Medicines Agency) regulatory guidelines.
- Coordinate across the business to ensure key regulatory timelines for Artwork implementation are met
- Respond as needed to document requests from legal for product litigation and defense related to labeling / artwork
- Collaborate with the manufacturing department and artwork center's to assist affiliates in creating accurate artwork instructions
- Communicate effectively with key stakeholder groups
-Identify and follow up with all market approvers as needed
- Provide support for the initiation of electronic Artwork Requests
- Conduct reviews on EU centralized procedure products for compliance with EMA submission requirements and according to EMA regulated templates
- Support and mentor other team members as necessary
Essential Skills & Qualification
- Bachelor's degree or equivalent in an appropriate discipline, plus related work experience
- Experience of working in a regulatory^environment, and have an understanding of regulatory labeling regulations and controls.
- In depth understanding of manufacturing and manufacturing plant processes/requirements and a knowledge of pharmaceuticals manufacturing preferred.
- Experienced user of electronic Artwork and Labeling Management Systems
- Excellent project management and time management skills
- Team player with excellent time management skills.
Software Competence: MS Office, MS Project, electronic Artwork and Labeling Management Systems
Valid Driving License: Not Required
Working Language(s): English
Requirement for Business Travel: Yes - Occasional travel may be required
Flexible Working Hours: No
Employer: Pharmaceutical Company
Employment Type: Agency Contract
Hours: Full time
Contract Term: 12 Months
Location: UK, Office Based (Some home working may be permitted) access near e.g. M25
Plan Start Date: ASAP, Please do not apply if you are unable to meet this start date.
Contract Benefits: Day Rate inclusive of benefits
MS Office, MS Project, regulatory affairs, labelling, artwork, manufacturing, quality
Assigned Consultant: Kirsty Clark at CSL Recruitment on 01932 234 681
Please feel free to call for a detailed Job Description or additional information
Applications are reviewed within 24hrs, applicants will only receive feedback if they demonstrate the skills the role requires in their application. The role maybe remarketed; if you applied for this role previously and were unsuccessful you will not receive a response. We request that non EU Nationals include evidence of right to work in the country concerned with their application to be considered. Do supply supplementary information on required location, notice period and expected salary/day rate if you are a new candidate.