Senior Regulatory Affairs Specialist
Kenvueは現在、以下求人を募集しております。
Location
Europe / Middle East / Africa, United Kingdom, Reading, Berkshire
Hybrid (Work from Office and Remote)
Reporting
Senior CMC Manager
Job Overview
The Senior Regulatory Affairs Specialist is accountable for all regulatory activities associated with EMEA medicinal products. Projects may include compilation and submission of applications (post approval and new submissions), resolution of Health Authority questions in cooperation with other functions, post-approval commitments and submission of variations/renewal applications where requested.
What You Will Do
* Prepares and submits regulatory submissions according to applicable EU regulatory requirements and guidelines for MRP or DCP to ensure maintenance and compliance of existing marketing authorisations.
* Collects and evaluates information on regulatory requirements for quality, preclinical and clinical data to meet applicable regulations.
* Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority, seeking opportunities to expedite regulatory approvals where possible.
* Prioritises, plans and monitors allocated projects against defined timelines.
* Develops and maintains a thorough understanding of the regulatory environment and supporting data requirements.
* Ensures that all assigned products comply with local regulatory and quality system requirements.
* Assists in ensuring that the enterprise Regulatory systems are accurate and fully maintained.
* Identifies & initiates local process improvement opportunities and manages changes as required.
* Assists in the preparation for internal and external audits and inspections in collaboration with others.
* Partners with other critical functions to execute plans to address crises and other sensitive issues.
Required Qualifications
* Relevant Bachelor's Degree or higher.
* 6+ years related regulatory experience, ideally on non-prescription EU procedures (MRP/DCP).
* Good attention to detail.
* Excellent communication skills, with the ability to articulate and express concepts clearly both verbally and in writing, particularly when simplifying complex regulatory or technical issues.
* Good interpersonal skills; able to build effective personal networks internally and externally.
* Collaborative with a strong sense of ownership, willing to be held accountable and be rewarded for delivering results.
* Strong organizational and time management skills with an ability to work under pressure.
* Able to work effectively in a multi-cultural, highly matrixed organization.
* Proficiency in English.
Desired Qualifications
* Knowledge of consumer healthcare environment and product development.
* Understanding of processes and departments within a healthcare company.
* Effective time and organisation management.
Benefits
* Competitive Benefit Package.
* Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More.
* Learning & Development Opportunities.
* Employee Resource Groups.
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