SRG are recruiting on behalf of a Global Pharmaceutical Company who have opened a new vacancy and are looking to recruit a Regulatory Artwork & Packaging Manager on an initial 12 Month contract based at their office in Walton Oaks post COVID.
This role is responsible for initiation of Packaging Artwork Requests, and will coordinate across business lines to assure key regulatory timelines for Artwork implementation are met. Following the initiation of the Artwork Request process in the business system, you will then track the approval status of packaging artwork components the EU region - max 28 country approvals.
- Liaise with European Country Offices in coordinating Regulatory new or update activity for packaging artwork labelling for Client products.
- Communicate/co-ordinate with key stakeholder groups for documentation of labelling artwork timelines.
- Liaise with Research Strategists on target dates for artwork completion on behalf of the Country Offices, and in conjunction with Manufacturing (working to SOPs/best practice guidelines).
- Raise and coordinate packaging artwork change controls in the Artwork system according to agreed timelines and established procedures, by performing the following activities:
- Support Affiliates with initiation of electronic Artwork Requests, ensure accurate entry of required data, and that all relevant regulatory documents are attached and routed for approval.
- Using Artwork system track/monitor the status of Artwork Requests and artwork component approvals with the Affiliates.
- In a timely manner, communicate with Country Offices and Manufacturing on status of Artwork Requests to ensure agreed regulatory timelines are met.
- Evaluate content of labelling updates and raise issues with the EU ALIM Lead and the Regulatory Strategists as appropriate.
- Develop and maintain relationships with relevant stakeholders.
- Use pharmaceutical packaging & artwork knowledge and experience to collaborate with Manufacturing's Artwork Centres to assist Country Offices in creating accurate Artwork change control instructions - so called 'Editors Copies'.
- Identify appropriate artwork Country Approvers and electronically route artwork to them for approval using the Artwork system.
- Interact and follow up with all Market Approvers as needed, and re-direct any Regulatory queries as they arise during the approval process.
- Bachelor's degree in any life sciences plus 2-4 years' related work experience.
- Extensive experience of working with regulated document management tools supporting; storage, retrieval, lifecycle management and tracking of labelling artwork for packaging components in a business enterprise system (e.g. ePALMS).
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Natasha.Rollason@srgtalent.com or +441753 589673
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