Regulatory Implementations Manager

3 weeks ago

Kent, United Kingdom SRG Full time

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).

Is your CV ready If so, and you are confident this is the role for you, make sure to apply asap.

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.

Responsibility 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 to agreed timelines 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 manufacturing and manufacturing Plant processes/requirements.

Must have capacity to make appropriate business decisions when facing uncertainty.

Team player/builder.

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