Regulatory - Artwork Implementation Manager

Full Job Description

SRG are currently looking for Regulatory Artwork Implementation Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory team on an initial 12 Month basis to be based at their offices in Kent (hybrid).

The Role:

• Responsibility for tracking and real-time transparency of the approval status of packaging components, in line with the EMA (European Medicines Agency) regulatory guidelines.
• Responsible for initiation of Packaging Artwork Requests and coordinating across business lines to assure key regulatory timelines for Artwork implementation are met.
• Tracking the approval status of packaging artwork components the EU region - max 28 country approvals, following the initiation of the packaging artwork requests process in the business system.
• Requirement (as necessary) to respond to document requests from legal for product litigation/defense related to labeling.

Key Responsibilities:

• Liaise with European Country Offices in coordinating Regulatory new or update activity for packaging artwork labeling for Client products.
• Communicate/co-ordinate with key stakeholder groups for documentation of labeling artwork timelines.
• Liaise with Research Strategists on target dates for artwork completion on behalf of the Country Offices.
• Raise and coordinate packaging artwork change controls in the Artwork system according toagreedtimelines and established procedures:
  • Support Affiliates with initiation of electronic Artwork Requests, ensure accurate entry of required data, and attachment of all relevant regulatory documents.
  • Track/monitor the status of packaging artwork requests and artwork component approvals with the Affiliates.
  • Communicate with Country Offices and Manufacturing on status to ensure agreed regulatory timelines are met.
• Evaluate content of labeling updates and raise issues with the EU ALIM Lead and the Regulatory Strategists.
• Develop and maintain relationships with relevant stakeholders.
• Use pharmaceutical packaging and artwork knowledge/experience to collaborate with Manufacturing Artwork Centres.
• Interact and follow up with all Market Approvers as needed, and re-direct any Regulatory queries.
• Work with minimal direct supervision. Working from home at times is a requirement at times.
• EU Travels if/as requested.

Skills/Experience Required:

• Extensive experience of working with regulated document management tools supporting; storage, retrieval, lifecycle management and tracking of labeling artwork for packaging components in a business enterprise system (e.g. ePALMS or similar).
• Bachelor's degree or equivalent in an appropriate discipline, plus related work experience (2-4 years).
• Must be familiar with Regulatory environment and have an understanding of labeling regulations and controls.
• Must be able to interact with Client's globally distributed Stakeholders in a professional manner.
• PC skills including spreadsheet, database management are required.
• Diplomatic with strong interpersonal, writing and verbal communication skills required.
• Strong, demonstrated project management experience and expertise.
• In depth knowledge of pharmaceutical manufacturing and manufacturing Plant processes/requirements.
• Must have capacity to make appropriate business decisions when facing uncertainty.
• Team player/builder.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.