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October 23 2018

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Job Offer: Regulatory Affairs Manager:PE Global

Job description:

Regulatory Affairs Manager

PE Global


   » Sligo
   » Negotiable
   » Permanent full-time
   » Updated 12/10/2018
   » Aoife Lomasney this job is expired SaveSave Apply Now

Job detail


This is a full time permanent function which can be worked remotely for the right candidate.
 

Currently assisting our client with the recruitment of a Regulatory Affairs Manager in Sligo. This is a full time permanent function which can be worked remotely for the right candidate. The function is responsible for providing global regulatory support for the Plant product portfolio. This will include leadership abilities in developing and implementing CMC regulatory strategy leading to prosperous registration and life-cycle management of unique and technologically complex products.

The Function:
   » Submits application for MIA (Marketing or Importer Authorization) to HPRA and maintain MIA current by submitting variations to HPRA as needed.
   » Represents the company when needed as interface with European agencies. Establishes effective working relationships with authorities and agencies.
   » Establishes and maintains effective working relationships with development and business teams. Ensures cross-functional perspectives/skills is incorporated into regulatory plans prior to decisions being made in cooperation with Israeli team and coordination with Director, Global Vaccine Regulatory Affairs.
   » Analyzes regulatory environment for impact on project/plans and communicates the impact appropriately to RA team and department director.
   » Leads the development and implementation of CMC regulatory strategy supporting both clinical and commercial products. Recognized CMC expert serving as primary project leader responsible for the development of CMC regulatory strategies, submissions and compliance activities.
   » Provides RA-CMC support and advice for all internal activities related to manufacturing, development, control, and quality of products in development in Sligo plant.
   » Ensures quality and compliance of regulatory activities by adhering to established corporate and functional processes, guidelines, and SOPs.
   » Leads with cooperation of the global team submissions in EU and MENA countries all regulatory activities in EU to obtain new EU and MENA licenses.
   » Develops strategy for pre-submission meetings with regulatory authorities to reach agreement on complex CMC requirements
   » Partner with Manufacturing, Quality, Technical/Analytical Development and Research to develop the CMC CTD content and ensure compliance with global health authority requirements in preparation for licensure.
   » Supports Global licensing processes.
   » Assists Plant manager in all regulatory inspections

Requirements
   » 10 years + industry practice with at least 8 years of Regulatory CMC practice.
   » BSc in a scientific/technical discipline required.
   » practice with vaccines would be preferable.
   » Strong Communication skills with the capability to expresses complex ideas clearly/succinctly both in writing and verbally.
   » Strong interpersonal, communication, coaching and training skills

this function will require some travel to MENA region. this function can be worked remotely also.

If you are interested in this function please email CV to or contact Aoife Lomasney on 0214297900

Although Information technology is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other appropriate positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert.
Ref: PEAL7409
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PE Global


   »  


   » Cork, Dublin, London
   » 021 429 7900
   » http://www.peglobal.net



Skills:

Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Sligo
Company Type Employer
Post Date: 10/12/2018 / Viewed 3 times
Contact Information
Company: PE Global


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