Cancel
Return to Job Search
CareerZone Limited

Regulatory Affairs Specialist

CareerZone Limited

  • Offaly / Westmeath / Galway
  • 40000 - 50000
  • Permanent full-time
  • Updated 07/10/2017
  • Aiden
this job is expired
Apply Now

Description

My Client a Global Pharmaceutical company based in the midlands are recruiting for a Regulatory Affairs specialist.

 

Regulatory Affairs Specialist

 

Applications are invited for the position of Regulatory Affairs specialist. This CMC regulatory role will involve the coordination, preparation and maintaining of a variety of regulatory CMC submissions to support both development and commercial products.

 

Job Description

 

· Collection, review and preparation of documentation in support of regulatory CMC submissions to regulatory agencies in the EU, US and other international agencies

· Regulatory support for R&D team for development projects

· Regulatory support for third parties for out licencing activities

· Create timelines and tracking deliverables to ensure that all submissions are submitted on-time

· Review and approve change controls related to proposed products/process changes and their impact on specific regulatory applications

· Plan and initiate projects based on consultation with Manager

· Update and maintain regulatory information management system as part of on-going responsibilities

· Attend relevant functional area and project team meetings as required

· Participation in initiatives aimed at improving internal regulatory standards

· Maintain departmental cGMP documentation and participate in cGMP project initiatives

 

 

Requirements

 

· A minimum of BSc or equivalent degree in scientific discipline.

· Minimum of 2-4 years of relevant regulatory pharmaceutical experience.

· Clear understanding of content and organization of regulatory submissions in eCTD format, as well as ICH and FDA guidance’s.

· Demonstrated track record of hands on experience in writing and reviewing Module 2 and 3 CMC documentation for drug products and drug substances for inclusion in a wide range of global regulatory CMC filings (e.g. DMF, IND, IMPD, MAA, NDA). In particular, previous experience with authoring DMFs is highly desirable.

· Detailed knowledge and interpretation of EU regulations and working knowledge of US and other countries.

· Motivated, self-starter with the ability to work independently with minimal supervision under tight deadlines.

· Ability to work effectively in a team/matrix environment and build productive working relationships within the Regulatory team and other departments.

· Excellent attention to detail

· Strong written and verbal communication skills including presentations.

· Demonstrates a sense of urgency around meeting commitments and timelines.

· Copes with changing priorities and a demonstrated ability to prioritize multiple projects.

 

 

 

Ref: REG21Ca
Apply Now
Report This Job

CareerZone Limited

CareerZone Limited

 

View Agency Profile

Show More

Similar Jobs for you

Email me jobs similar to: Regulatory Affairs Specialist

Please enter your email address

Please enter a valid email address

We use cookies to customise our website for you, giving you the best possible user experience. If you continue without changing your settings, we’ll assume that you are happy to receive this personalisation. Find out more about our cookie policy

Accept & Close