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.
ABOUT THE ROLE:
- 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)
ABOUT THE PERSON:
- 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 (firstname.lastname@example.org) to discuss further.
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