Regulatory - Artwork Implementation Manager
Posted 30/04/2024 by SRG
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.
- Type:
- Contract
- Start Date:
- ASAP
- Contract Length:
- 12 Months
- Contact Name:
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- Telephone:
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- Job Reference:
- BBBH143570_1714483355
- Job ID:
- 221564706
- Applications:
- Less than 10
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