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Job Details

Regulatory Officer Compliance

Company: Thornshaw Recruitment
Location: Dublin, Republic of Ireland
Reference: LD9607
Closing Date: 16 Dec 17
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

Our client, a global pharmaceutical company,  are currently recruiting for a Regulatory Officer Compliance. This is a 12 month contract role initially.

Requirements:

Our client, a global pharmaceutical company,  are currently recruiting for a Regulatory Officer Compliance. This is a 12 month contract role initially.

Objective:
•    Manage new applications, variations and maintenance of International MA’s 
•    Support New Product Introductions Internationally
•    Gap analysis and remediation of International CMC documentation 
•    Assist with development of International regulatory strategy and regulatory intelligence 
•    Collaboration with stakeholders to support active MA’s and related activities
•    Perform assigned tasks right first time, in accordance with best practice and internal processes
•    Other tasks as requested by Manager

Responsibilities:
DOSSIER MANAGEMENT 
•    Compile and deliver hard copy or eCTD of MA dossiers for requesting country(s)
•    Development of MA dossiers according to local requirements and best practice guidelines
•    Timely compilation of registration dossier to meet project timelines
•    Review CMC dossier packages for accuracy, completeness and compliance 
•    Identify and obtain deficient information in order to complete compilation in a timely manner
•    Due diligence audits of CMC dossiers against current manufacturing procedures and processes
•    Identification and remediation of risks or deficiencies related to the CMC quality of the dossier 
•    Communication of issues obtaining information necessary for dossier development
•    Liaise with appropriate stakeholders to resolve issues surrounding successful dossier build
•    Regulatory advice regarding proposed CMC changes to the registered dossiers
•    Update of relevant RA database(s) and associated QA systems

REGISTRATION PROCESS
•    Manage international regulatory submissions according to company strategy and project plans
•    Timely management of dossier activities in order to support submissions and approvals
•    Dispatch of documentation to International affiliates 
•    Tracking of CMC packages delivered to affiliates and monitoring final delivery to regulators
•    Support responses to Health Authorities' queries and deficiencies 
•    Liaise with affiliates and stakeholders in order to maintain, modify and renew product licences 
•    Support New Product Introductions and complete related activities effectively

PROJECTS AND TEAM WORKING
•    Actively participate in assigned projects by providing regulatory guidance to multi-disciplinary team
•    Work as part of a team to ensure required documentation is available on time, complete and 
REGULATORY GOOD PRACTICE
•    Take ownership and be accountable for work completed
•    Keep all trackers and databases up-to-date

Requirements
•    Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
•    1 – 2 year experience in a regulatory affairs environment 
•    Relevant experience in, and general knowledge of, the pharmaceutical industry
•    Knowledge of EU and other regions current registration and dossier requirements 
•    Knowledge of how to source registration requirement information
•    Strong computer competency e.g. Word, Excel, Access, Powerpoint etc
•    Experience with RA and QA pharmaceutical systems

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

Apply for this job: Regulatory Officer Compliance

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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