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Senior Regulatory Affairs Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBee Careers Full time

About the Role:

The Senior Regulatory Affairs Specialist will be responsible for overseeing the day-to-day activities of the Regulatory Affairs team and ensuring compliance with regulatory requirements.

  • Develop and implement effective regulatory strategies to ensure compliance with EU and international regulatory agencies.
  • Prepare and submit regulatory applications, including new Marketing Authorisation Applications (MAAs) and variations.
  • Review and write/contribute to CMC sections for regulatory submissions.
  • Maintain relationships with regulatory authorities, including HPRA and EMA.

Required Skills and Qualifications:

  • A degree in Pharmacy, Life Sciences, or a related discipline.
  • Postgraduate qualifications in Regulatory Affairs or Pharmaceutical Sciences are advantageous.
  • Minimum of 7 years of progressive experience in Regulatory Affairs within the pharmaceutical industry.