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Regulatory Affairs Specialist – Cork

Regulatory Affairs Specialist

Optimize Recruitment are partnering with a leading pharmaceutical client to recruit two Regulatory Affairs Specialists on a permanent basis as they grow their headcount in 2021.

These roles are responsible for maintaining regulatory compliance for the companies products in the US market.


  • Perform Regulatory Affairs activities ensuring compliance with applicable regulations and requirements (FDA, DSCSA, CBP, DEA)
  • Issue NDCs in accordance with CFR guidelines
  • Issue UPC codes for new item set up
  • Manage drug listings lifecycle (SPL review, re-certification and de-listings)
  • Contribute and respond to Competent Authorities’ queries and deficiencies in a timely manner
  • Support regulatory authority compliance audits

Support labelling activities including but not limited to:

  • Review, approve and monitor artwork changes for contracted, commercialized and pipeline private label products for the US market to ensure compliance
  • Act as a key contributor on labeling aspects by applying best practices and performing regulatory due diligence and impact assessments on labeling requirements
  • Interpret, analyze, compare and make decisions regarding labelling content, in collaboration with labelling stakeholders
  • Maintain a good understanding of existing and emerging pharmaceutical regulations and evaluate the impact on the private label business
  • Liaise effectively with internal departments and external suppliers to support the timely introduction of new products to market
  • Preparation of monthly metrics and reports to monitor and cross-compare the quality systems
  • Be flexible within the Regulatory function to meet the needs of the growing business using technical expertise, skills, knowledge and experience

Experience required:

  • Educated to degree level or higher in Chemistry, Microbiology or other scientific discipline
  • 5+ years regulated pharmaceutical experience; 3+ years regulatory affairs experience
  • Thorough understanding of regulatory and compliance guidelines within pharmaceutical manufacturing with an emphasis on labeling content
  • Excellent communication skills with ability to communicate at all levels within the organization
  • Proven analytical and problem-solving skills and the ability to transfer findings into report and presentation formats
  • Familiarity with concepts of Regulatory Approval process for generic pharmaceutical products an advantage

For a confidential discussion, please contact Lee Doheny in the strictest of confidence on 0858072559 / lee@optimizerecruitment.ie
Please note your CV will never be released without your prior approval.
JOB REF: LD-22188

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