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...
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.
- 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.
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.