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Regulatory Affairs Specialist II

Location: Boca Raton, Florida Salary: competitive
Sector: Pharma & Biotech Type: Contract

Title: Regulatory Affairs Specialist II

Location: Boca Raton, NJ

Type: Contract-to-Hire

Rate: To be discussed…

Responsibilities:

  • Prepare, compile and develop product registration data for the semi-regulated and regulated market.
  • Be well informed about eCTD, ACTD & country specific guidelines.
  • File regulatory documents within budget and timeline.
  • Interact with various departments/teams to collect documents required for dossier compilation on time as per regulatory norms.
  • Coordinate with manufacturing facilities for product samples, specifications, laboratory reports and packaging materials.
  • Interact with various external regulatory agencies.
  • Review the quality and analytical data as per the pharmacopoeia, specification, batch manufacturing
  • records, stability, finished product / packaging material data for the purpose of compilation of the dossier.
  • Review and manage applications for License and DMF.
  • Review and respond to technical queries related to product registration from FDA.
  • Maintain an online report of various submission status as well as queries at various stages of all countries.

Requirements: EXPERIENCE REQUIREMENTS:

  • Experience in eCTD publishing (Required).
  • 1 year pharmaceutical regulatory experience (Required).
  • 1 year pharmaceutical product registration experience in non-US country (Required).
  • 3-6 years experience in product registration in EU, TGA, FDA (Preferred).
  • Experience within a pharmaceutical/medical device organization and current Good Manufacturing Practices (cGMPs)/Quality System (QS) Regulation is strongly preferred.
  • Proficient in computer skills with eCTD software, template creation for submission, Word/Excel/MS Office Suite and ERP systems.

Bachelor's Degree in science, biotechnology, or related discipline

Sthree US is acting as an Employment Business in relation to this vacancy.