12 Month Contract
Weybridge / Hybrid role
Pay rate £286.50 per day via Umbrella (inside IR35)
We are looking for a Regulatory Manager to join our dynamic, high performing team, working on a wide range of Consumer products such as Advil, Alli, Nicotinell, Nexium, Otrivin, Panadol, Voltarol, Zovirax.
As Regulatory Executive, you will be accountable for co-ordinating and delivering the timely preparation of European variations and other applications for the GSK Consumer portfolio as quickly and efficiently as possible once the required data & documents are available from relevant sources, such as R&D, sites or reference markets. This role will be to specifically support separation regulatory activities for EU products: variations for CP, MRP and DCP medicines (legal name change, manufacturing site name changes etc…), medical technical file updates for medical devices and cosmetics notification / PIF updates for products within the EU region portfolio.
This role reports to the EU Regulatory Strategy & Innovation Lead.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities involve the following:
· Comprehensive understanding of EU Regulatory requirements, specifically for maintenance activities such as legal name change variations, so to efficiently plan and communicate these requirements to stakeholders (CDMA, CMC etc) to ensure timely & complete delivery of these documents.
· Agree & communicate plans required for Regulatory submissions in markets to meet variation timings, expectations and milestones.
· Proactively seek updates and changes in Regulatory Intelligence for market requirements and communicate these to relevant stakeholders.
· Partner with Central Regulatory colleagues (ie CMC), CDMA, Manufacturing and LOCs to ensure clear communication and understanding of priorities, planned activities and process requirements.
· Contributes as Regulatory representative into project initiatives on behalf of GSK Consumer Healthcare. Ensure adequate Regulatory support is provided to deliver project objectives.
· Manage the execution and delivery of ‘Right First Time’ dossiers, ensuring filings for planned initiatives are completed as planned.
· Prepare/ensure availability of high-quality documents required to support applications / notifications and ensure maintenance and lifecycle management in accordance with market data requirements.
· Display ability to resolve unexpected issues/challenges and minimize impact by communicating and escalating to peers and senior management when required
· Expertise in using required IT Regulatory systems, including Documentum.
· Critical assessment of processes and systems, initiates improvements as required.
You will have an established understanding of the Regulatory Affairs role, with previous experience in a similar Regulatory Affairs role. As you will assume responsibility for several products with various legal status’ including cosmetics, medicinal and medical devices, this position requires an understanding of the differences between the regulations and associated requirements for these different product types.
· Degree level education in Chemistry, Pharmacy, Pharmaceutical or Life Sciences
· Experience in a related Regulatory Affairs role which could have covered the following:
o Direct experience with medicinal product regulations
o Direct experience with cosmetic product regulations
o Experience with medical device regulations
o Proven record of developing and leading regulatory strategies for complex situations
o Experience of working flexibly across a portfolio of products
o Knowledge of eCTD and related electronic submission processes.