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Senior Regulatory Affairs Officer

Employer
Thornshaw Recruitment
Location
Dublin (City), Leinster (IE)
Salary
Negotiable
Start date
21 Sep 2020
Closing date
5 Oct 2020

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

My client, a global healthcare company now have a vacancy for a Senior Regulatory Affairs Officer.
Your role:
You will provide regulatory affairs support to support and manage International MAAs and Lifecycle activities for our current and actively growing range of pharmaceutical products, CAMs, our R&D pipeline products’ therapeutic indications and international markets.  
Responsibilities:
•    Acts as responsible Regulatory Team member for assigned regulatory projects (medicinal products, CAMs and ad hoc R&D pipeline) 
•    Preparation and filing of submissions including; life-cycle maintenance variations, initial MAA filling, labelling updates, renewals, obtaining CPPs, Marketing Authorisation Transfers (MATs) and publishing.  
•    Prepares and/or reviews regulatory documentation for DCP, MRP and National applications in line with assigned timelines.  
•    Support the strategic and operational planning and registration of CAMs in global markets 
•    Actively participates and employs effective communication practices with internal customers (CMC, CAMs team, Supply Chain, Quality, Legal, Clinical, Medical, Pharmacovigilance, globally based Regulatory Managers).  
•    Prepare status reports and metrics for assigned projects 
•    Perform assigned work according to current best good regulatory practice and in compliance with current legislation and regulatory guidelines at all times. 
•    Any other duties as assigned by your Manager 
•    Promote best regulatory practice and approach in business operations 
•    Promote and develop best use of regulatory tools and e-platforms  
•    Support Change Control and Quality Management process within GRA •     Any other duties as assigned on ad hoc basis      

Education and Experience:
•    >3 years pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions)  
•    Experience of EU DCP and MRP MAAs  
•    Experience of emerging markets / international Row markets and regulatory filings is  
•    Quality control review of technical/ regulatory documents  
•    Understanding of Regulatory strategy and determination of documentation requirements Compliance with SOPs, Change controls and regulatory best practices  
•    Publishing: eCTD Office and or NEES – an advantage 
•    IT Literate and working familiarity with regulatory publishing platforms  
•    Project management experience  
Experience of CAMs/Food Supplements/Borderline/Nutritional products – advantageous

For full details contact Tina at +353 1 2784671 or email tdunne@thornshaw.com
Thornshaw Scientific is a division of the CPL group www.thornshaw.com

Company

thornshaw-title

Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment.  In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.

Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.

Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.

Our Industries

We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years. 

Our Specialities

Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.

Our Mission

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For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com

 

Company info
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