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Regulatory Affairs Manager

Employer
Thornshaw Recruitment
Location
Dublin (City), Leinster (IE)
Salary
Competitive
Start date
27 Sep 2019
Closing date
27 Oct 2019

View more

Discipline
Regulatory Affairs, Compliance, Regulatory Writing
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

We are now recruiting for a Regulatory Affairs Manager for our client to join a rapidly growing Global Regulatory Affairs team located in Dublin city. The Dublin team provide regulatory operations and strategy support to their current and growing product portfolio, therapy areas and international market presence. 
  
KEY RESPONSIBILITIES 
•    Acts as responsible Senior Regulatory Team member for assigned regulatory projects 
•    Preparation and responsibility for regulatory submissions including Marketing Authorization Transfer, CMC variation filling, initial MAA filling, labelling updates, renewals, CMC authoring and \ or updates as required. 
•    Prepares and/or reviews regulatory documentation for DCP, MRP and National applications in line with Corporate needs and timelines. 
•    Actively participates and employs effective communication practices with internal customers (CMC, Supply Chain, Quality, Legal, Clinical, Pharmacovigilance, Regional Regulatory Managers, Regional Heads). 
•    Understands the Scope of Work, timelines and deliverables for a given project. 
•    Manage Regulatory Projects and /or regulatory team members
•    Prepare status reports and metrics for assigned projects
•    Perform assigned work according to current best regulatory practice and in compliance with current legislation and regulatory guidelines.
•    Promote best regulatory practice and approach in business operations
•    Promote and develop best use of regulatory tools and e-platforms 
•    Any other duties as assigned by your Manager

MINIMUM REQUIRED EDUCATION AND EXPERIENCE 
Degree in Pharmacy or life science-related degree plus at least 6 year’s relevant human pharmaceutical experience with focus on filing and lifecycle maintenance of marketed products in Europe and/or emerging markets 
•    Writing and preparation of relevant CTD (Common Technical Dossier) documents to support submissions, in collaboration with Technical/CMC/Clinical/Labelling experts 
•    Experience of EU DCP and MRP MAAs 
•    Experience of emerging markets / international RoW markets and regulatory filings
•    Quality control review of technical/ regulatory documents 
•    Understanding of Regulatory strategy and determination of documentation requirements, timelines, budgets and filing options
•    Compliance with SOPs, Change controls and regulatory best practices 
•    Pharmaceutical artwork review and sign-off
•    Project management experience - an advantage 
•    Experience of Women’s and/or Men’s healthcare – an advantage
•    Experience of US Regulatory Affairs – an advantage
•    Experience of Medical Devices – an advantage

For full details and confidential discussion please contact Tina at +353 1 2784671 or email your cv to tdunne@thornshaw.com

Company

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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
Website

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