Regulatory Associate/ Product Lifecycle Management

6 days ago

Weybridge, United Kingdom Experis LTD Full time

**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
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 differentproduct types.
**Key Responsibilities**
**Planning**
- 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.
- 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.
'
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

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