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Job Details

Regulatory - Packaging & Artwork Manager

Company: SRG Clinical
Location: Surrey
Reference: J25418
Closing Date: 12 Mar 18
Type: Part Time
Salary (£): Negotiable
Benefits:

Job Summary:

My Client a Global Pharmaceutical Company has opened a new vacancy and is looking to recruit a Regulatory - Packaging & Artwork Manager on an initial 12 Month contract to be based at their offices in Surrey.

Requirements:

The Role:

To be responsible for tracking and real-time transparency of the approval status of packaging components, in line with the EMA regulatory guidelines. 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.



Responsibilities:

* 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 (PARS), ensure accurate entry of required data, and that all relevant regulatory documents are attached and routed for approval. - Track/monitor the status of PARs and artwork component approvals with the Affiliates. - In a timely manner, communicate with Country Offices and Manufacturing on status of PARs 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.
* 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’.
* 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 or equivalent in Life Sciences.





Education:

Bachelors degree in Life Sciences.



If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

Apply for this job: Regulatory - Packaging & Artwork Manager

Contact Information:

Address:  Head Office
SRG Clinical 9 Devonshire Square London United Kingdom
EC2M 4HP
England
Tel:  +44 (0)203 096 4700
Website:  Visit Our Web Site

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