Senior Manager Regulatory Affairs – CMC

Due to continued growth my client – Global Biopharma company – seek an experienced CMC Regulatory Affairs Professional to join their established team in their Global HQ operated from Dublin. This international company focuses on improving patients’ lives by identifying, developing and commercialising meaningful products that address unmet medical needs. Since their founding they have focused on putting the patient first and this remains their priority as they continue to develop, acquire and commercialise new treatment options for patients with challenging conditions that no one else is tackling. Currently employing over 1000 staff globally with offices in the U.S. and Europe they are a continually growing company with a broad portfolio and a very healthy pipeline.

The Role

Reporting to the Head of Global CMC – as Regulatory Affairs Global CMC Manager you will be responsible for managing the registration and CMC regulatory support for commercial and development projects worldwide.

The Person

In order to be considered you must have the following:

  • BSc/BA in science discipline or related
  • 5 years industry experience in Pharmaceutical or Biotechnology- specifically within CMC
  • Solid working knowledge of CMC regulatory and ability to generate clear, well-argued positions
  • Must have experience with CMC regulatory documents (MAA, BLA, variations, responses and CTAs/INDs)
  • Knowledge of FDA, EMA and ICH guidelines
  • Fluent English
  • Eligible to work in EU

The Benefits

  • Competitive salary
  • Pension
  • Bonus
  • Healthcare
  • Stock options

To learn more, apply online or contact Gillian McMurrough +353 1 6321827 for a confidential chat.

Salary: €75000 - €82000 Location: Dublin City Centre