Role Title: Regulatory Associate/ Product Lifecycle Management
Duration: 6 months
Location: Weybridge / hybrid role
Rate: £ 408.61 per day via umbrella (inside IR35)
Role purpose / summary
Job Purpose why job exists / what it must achieve
The objective of the Product Lifecycle Management (PLM) team is to co-ordinate and deliver the timely preparation of global renewal applications, administrative variations and safety reporting (ie PBRERs) for the company 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 assume responsibility for several products with various legal status' incl. medicinals, cosmetics and medical devices. This position requires an understanding of the differences between the regulations and associated requirements for these different product types.
Key Responsibilities
Planning
- Comprehensive understanding of Global Regulatory requirements, specifically for maintenance activities such as renewal application and post-launch variations, so to efficiently plan and communicate these requirements to stakeholders (SERM, CMC etc) to ensure timely & complete delivery of these documents.
- Agree & communicate plans required for Regulatory submissions in markets to meet renewal, admin variation and safety reporting timings, expectations and milestones.
- Proactively seek updates and changes in Regulatory Intelligence for market requirements and communicate these to relevant stakeholders.
- Partner with Global Regulatory colleagues (ie CMC), GSM, Manufacturing and BUs to ensure clear communication and understanding of priorities, planned activities (i.e. renewals) and process requirements.
- Contributes as Regulatory representative into priority project initiatives on behalf of the company. Ensure adequate Regulatory support is provided to deliver project objectives.
- Displays expansive thinking and makes regulatory decisions understanding consumer and market insights
Implementation
- 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 renewal, admin variations and safety reporting applications and ensure maintenance and lifecycle management in accordance with market data requirements.
- Provide Centre of Excellence support to BUs and LOCs for region and local initiatives (eg NPI / Geo), where legalised documentation is required, aligned with CMC priorities.
- Display ability to resolve unexpected issues/challenges and minimize impact by communicating and escalating to peers and senior management when required.
Knowledge
- Expertise in using required IT Regulatory systems, including Veeva Vault REQUIRE and Documentum.
- Critical assessment of processes and systems, initiates improvements as required
Skills required / nice to have
This is a role that requires an established understanding of the Regulatory Affairs role, having gained experience in a similar position of Regulatory Affairs role.
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Previous experiences would have covered the following:
- Direct experience with medicinal product regulations
- Direct experience with cosmetic product regulations
- Experience with medical device regulations
- Proven record of developing regulatory strategies for complex situations
- Experience of working flexibly across a portfolio of products
- Awareness of regulatory processes in different geographic regions, e.g. Emerging markets, Japan.
- Knowledge of eCTD and related electronic submission processes.
- BSc or relevant job-related experience
All profiles will be reviewed against the required skills and experience. Due to the high number of applications we will only be able to respond to successful applicants in the first instance. We thank you for your interest and the time taken to apply!
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Who will I be working with?
http://www.gsk.com/en-gb/careers/meet-our-people/
