Regulatory Affairs Specialist/Manager

On behalf of our client, a global pharmaceutical company, we are currently recruiting for a Regulatory Affairs Specialist/Manager

This is a permanent, full-time role in the local commercial affiliate office.  The candidate will be responsible to manage all regulatory strategies and the preparation of regulatory documents for the Irish and Maltese markets.
 

Responsibilities:

• Manage and implement all regulatory affairs projects for the Irish affiliate for marketed and non-marketed products in a timeline manner, i.e. license maintenance; lifecycle management, new market authorisation applications and the submission and approval of variations, renewals, PSURs
• Manage and oversee regulatory strategies and the preparation of regulatory documents targeted for the Irish Market within required timelines
• Manage regulatory files for Malta
• Review and approve regulatory documents (SPCs, PIL and labelling) and implement approved artwork/packaging in line with regulations.
• Manage all regulatory aspects for new product launches
• Prepare regulatory strategies and contribute to business decision making in relation to product launches and product changes
• Management and approval of promotional material and advertising
• Preparation and submission of product price applications
• Prepare and deliver training materials for internal training, and conduct training session on relevant scientific and regulatory topics
• Lead investigation is potential non-compliance issues and coordinate with relevant stakeholders and colleagues as necessary.
• Regulatory surveillance and update of affiliate teams of new or topical issues for consideration
• Manage medical information queries from the marketplace and provide timely, scientific responses to enquirers
• Act as back-up for pharmacovigilance and quality (product complaints, recalls etc) within the company
• Work collaboratively with relevant Global and country teams to establish and implement regulatory strategies within agreed timescales
• Advise the local teams on regulatory updates, when required.
• Interface and liaise with relevant government agencies (e.g. HPRA, HSE) as required to ensure that the company is in compliance with all regulations and laws in relation to products, packaging, production, marketing and advertising. 

Requirements:

• BSc in science/life sciences degree
• 4 years plus experience in a regulatory affairs environment
• Knowledge of current EU registration and dossier requirements
• Experience with systems and tools specific for RA and the pharmaceutical sector
• Effective project management, time management, organisation and prioritisation skills
• Excellent verbal and written communication skills
• Occasional travel may be required. 

If you are interested in applying for this role please call Linda on +353 1 2784671 or email ldunne@thornshaw.com 
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com
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