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Job Details

Regulatory Affairs Team Leader

Company: Thornshaw Recruitment
Location: Dublin, Republic of Ireland
Reference: LD9632
Closing Date: 21 Dec 17
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

Our client, a Dublin based pharmaceutical company, are currently recruiting for a Regulatory Affairs Team Leader. 

Requirements:

Our client, a Dublin based pharmaceutical company, are currently recruiting for a Regulatory Affairs Team Leader. 

ROLE & RESPONSIBILITIES
1.    Participate in setting out the short- and long-term strategy for the RA department in Ireland with Head of Product Development 
2.    Develop and maintain principles for submissions, dossier reviews and authoring of Module 3 documentation
3.    Contribute to the choice of regulatory service providers 
4.    Manage team resources for Regulatory development- and submission projects
5.    Overall responsible for progress-, budget- and timeline reporting
6.    Act as Regulatory responsible for part of the projects

MAIN TASKS
1.    To allocate projects to the team members and manage resources for ongoing RA projects
2.    To build and evaluate strategies for process, communication and information flow between stakeholders during the RA phase
3.    To highlight RA process- and resource bottlenecks, suggest and participate in organizing solutions to improve department workflow
4.    To draft job descriptions for new RA staff, screen candidates, participate in selecting new team members for employment and set team goals
5.    To report project progress, -budget and timelines and ensure the quality of reporting
6.    To ensure that the team meets the timelines, minimize delays and ensure data quality in company overview files and archives
7.    To set out the team framework and supervise team in the planning of RA projects and appropriate project scope
8.    Act as Regulatory responsible for part of the projects

POSITION REQUIREMENTS

Minimum Qualification:    
MSc or higher in a life science discipline; Experience with team leadership; Experience with EU and US regulatory projects is desired.
Minimum Experience:    
12 years of experience in a pharmaceutical environment (industry or authority) specifically in a RA department of a smaller company and solid experience with Module 3 documentation
Languages:    Good English skills is a must (written and oral)

ABILITIES

1.    A strategic mindset and a leading character with a positive spirit and strong communication- and motivation skills. Good understanding of and respect for cultural differences and the capacity to work effectively in a multicultural environment. 
2.    Ability to manage internal and external teams in person and remotely.
3.    Ability to understand different working styles and support team members in achieving department goals
4.    Knowledge of project management techniques and tools. Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies.
5.    Ability to understand and analyze scientific data and results and review scientific documents.

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 Affairs Team Leader

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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