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Regulatory Affairs Specialist

Type Permanent

Salary Negotiable

Location Cork (All)

Ref # 7272

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Barden are delighted to be supporting our rapidly growing Global Pharmaceutical and Healthcare client in their search for a Regulatory Affairs Specialist. The Regulatory Affairs Specialist will be responsible for ensuring compliance, managing risk and minimising supply interruptions across a large portfolio of OTC Drug, Medical Device, Foods and Cosmetic products.


  • Perform Regulatory Affairs activities ensuring compliance with applicable regulations and requirements (FDA, DSCSA, CBP, DEA)
  • Understand and review compliance requirements across a portfolio of OTC Drugs, Medical Devices, Combination Products, Cosmetics, and Food
  • 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)
  • Compile technical package for Centre for First Data Bank registrations.
  • Support Global Unique Device Identification GUDID registrations.
  • Review, approve and monitor artwork changes for contracted, commercialized and pipeline products for the US market to ensure compliance in accordance with NDA/ANDA filings, OTC monographs, FDA and private label brand guidelines.
  • Act as a key contributor on labelling aspects by applying best practices and performing regulatory due diligence and impact assessments on labelling requirements (including but not limited to CBP and COO requirements)


  • 5+ years regulated pharmaceutical experience.
  • 3 years regulatory affairs experience  
  • Thorough understanding of regulatory and compliance guidelines within pharmaceutical manufacturing (Ideally with an emphasis on labelling content)

Please get in touch with Aidan Crowley in Barden ( to discuss further.


Hi, we’re Barden.  We’re the Partner Led Talent Advisory & Recruitment Firm that puts Talent first. With practices across Accounting & Tax, Business Support, Financial Services, Legal, Life Sciences, Supply Chain, and Technology, we help build world-class teams for Ireland’s top companies and we help top Talent achieve their ambitions. Simple.

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Working with Aidan’s team

Aidan Crowley leads a team of life sciences talent advisory and recruitment experts that work exclusively with life sciences professionals across Ireland. With a deep understanding of leading businesses, team structures and cultures, Aidan and his team go to great lengths to provide a consultative and supportive services to the talent they work with. Aidan and his team are where life sciences professionals go for advice before they start looking for a job.

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