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Senior Associate Regulatory Affairs

Job Seekers Ireland Science Life Science

Job Summary

  • Dublin
  • Contract
  • BBBH765645
  • Sep 01, 2020
  • Competitive
Job Description

A great opportunity for an experienced RA Associate to progress into a senior role with a global Biopharma.

This role reports directly to the Senior RA Manager and works in collaboration with the Site RA CMC Team and other Global/Regional Teams as needed.

Responsible for the registration document(s) procurement, preparation and coordination.

Serve as liaison with other functional teams at the site in support of registration activities and generation and management of required documentation.

Key Activities

  • Registration document(s) procurement, preparation, coordination submission and archival
  • Coordinates legalization and delivery of registration documents following the instructions provided in the request.
  • Maintains tracking and organization of documentation, including uploading in CSD tool or other document repository.
  • Supports the Site Regulatory CMC Team in the compilation and preparation of marketing application and post-approval submissions as needed.
  • Maintaining and optimizing relevant databases, tracking systems and document management processes to support the licenses.

Knowledge and Skills

  • Excellent written and verbal skills
  • Knowledge of Good Manufacturing Practices (GMP) and good documentation practices
  • Strong written and oral communication skills
  • The applicant should have basic knowledge regarding CMC sections of a Marketing Application (BLA, NDA, IND, NDS)
  • Proficient use of MS Office tools, SharePoint and strong computer aptitude.
  • Must have ability to work within team environment, but maintain a level of autonomy for managing daily tasks and activities
  • Solid working knowledge on document management systems such as Documentum.

Education & Experience

  • Bachelor/Master's degree (Regulatory, Life Sciences, Biotechnology or related discipline)
  • Candidates MUST have GMP site experience
  • Min 2 years RA experience (CMC experience preferred)

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

Consultant Details

Consultant Details

Aoife Duggan
Aoife Duggan
  • Senior Consultant
  • +353 21 2300300
  • aduggan@morganmckinley.com