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Job Details

Senior Regulatory Affairs Officer

Company: Thornshaw Recruitment
Location: Dublin, Republic of Ireland
Reference: LD9924
Closing Date: 10 Jan 19
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

On behalf of our client, a global pharmaceutical company, we are currently recruiting for a Senior Regulatory Affairs Officer Compliance role.

Requirements:

On behalf of our client, a global pharmaceutical company, we are currently recruiting for a Senior Regulatory Affairs Officer Compliance role. 

All general RA activities as per RA Officer Compliance job specification e.g.:
o    Manage new applications, variations and maintenance of International MA’s 
o    Gap analysis and remediation of International CMC documentation 
o    Build and develop International regulatory strategy and regulatory intelligence 
o    Collaboration with stakeholders to support active MA’s and related activities
o    In addition to items outlined below
•    Lead by example in completing tasks and interacting with colleagues and stakeholders
•    Team mentoring and training
•    Continuous development awareness
Other activities as assigned by Team Leader / Manager / Head
DUTIES:
SENIOR  OFFICER EXPECTATIONS
•    Lead project teams or working groups as directed by management
•    Provide mentoring and support for new starters and less experienced team members
•    Representing RA Compliance at relevant meetings / telecons / WebExs
•    Lead by example to ensure tasks are completed in a timely and effective manner
•    Lead by example by displaying ownership and taking accountability for assigned activities
•    Proactive identification and reporting of potential issues to management
•    Ongoing process and systems assessment to enable continuous development
•    Develop / deliver training as appropriate
•    Contribute to the development and implementation of RA policies, processes, SOPs and other
•    Perform assigned work according to good regulatory practice and in compliance with current legislation and regulatory guidelines

DOSSIER MANAGEMENT 
•    As per RA Officer Compliance job specification
•    Peer review of dossier documents for accuracy, completeness and compliance
•    Oversee dossier build timelines for any assigned team projects
•    Timely escalation of issues causing delays with dossier development

REGISTRATION PROCESS
•    As per RA Officer Compliance job specification
•    Assist RO’s with managing risks and evolving timelines, and with remediation of issues

PERSONAL DEVELOPMENT
•    As per RA Officer Compliance job specification
•    Identify and communicate perceived key strengths to management in order to work more effectively and assist manager with smart project planning 
•    Identify and communicate perceived areas for improvement to enable development of effective Personal Development Plans  and Group Training schedules

Requirements

•    Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
•    Minimum 3 years 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 and ability to source International registration requirement information
•    Excellent computer competency e.g. Word, Excel, Access, Powerpoint etc
•    Experience with systems and tools specific for RA and pharmaceutical sector
•    Results and performance driven – deliver results that meet or exceed expectations
•    Ability to lead and support several concurrent projects/products with strong multi-tasking abilities 
•    Develop productive relationships within cross-functional teams
•    Ability to prioritise decisions and address critical issues impacting the business
•    InternationalAble to cope with evolving deadlines effectively 
•    Possess cultural awareness and sensitivity
•    Flexibility is a key requirement for this role

For more information and to apply for this role please call Linda on +353 1 2784671 or e-mail ldunne@thornshaw.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Www.thornshaw.com Tel: +353 1 2784671
#THR2018

Apply for this job: Senior Regulatory Affairs Officer

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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