JOB SUMMARY
Supports the implementation of regulatory operational activities in Emerging Markets in Europe, Africa, Middle East (EAME) and provides regulatory support for the registration and maintenanceh activities of medicinal products.
Develops and maintains knowledge of regulatory procedures in the region.
Builds and maintains relationships with Regulatory and other staff within and outside the region to ensure effective communication and efficient implementation of regulatory activities.
KEY DUTIES AND RESPONSIBILITIES:
New Product Registration
• With supervision ensures effective implementation of the assembly and preparation of core files for Marketing Authorisation Applications.
• With supervision, works cross-functionally to respond to questions from Regulatory authorities to gain product approvals
• Ensures effective planning and tracking of activities.
• Ensures effective co-ordination of the review and approval of product-related packaging as required, to ensure regulatory compliance.
• With supervision supports the definition and communication of regulatory strategy in support of new product registration, in line with commercial objectives.
• With supervision, ensures that teams and functional groups are provided with clear, constructive regulatory advice and intelligence.
Marketed Product Maintenance
• With supervision, provides regulatory support for assigned products and inputs to project teams via Global Regulatory Teams.
• With supervision, ensures effective implementation of variations and renewals for the region.
• With supervision, implements regulatory activities in support of lifecycle management and maintenance in the region
• With supervision works with regulatory staff “in country” to support the markets.
• With supervision provides clear communication to “in country” and global regulatory staff on planned activities and priorities, on a regular basis.
MINIMUM REQUIREMENTS
• Life Sciences Graduate, ideally with post-graduate qualification in a relevant area and/or business qualifications.
• Some knowledge of International pharmaceutical regulations and guidelines.
• Extensive Regulatory Affairs experience, including a successful track record in the registration and maintenance of pharmaceutical products within Europe.
• Experience in cross-functional project teams.
Even if you are unsure on your suitability for this position but you are looking at the possibility of some progression in your current job or a change in your career path, please feel free to contact me for a friendly chat to explore any options that may be open to you.All enquiries will be dealt with in a strictly confidential manner. Call Matt on 01293 776644 or email me at mhart@barringtonjames.com
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