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Senior Regulatory Affairs Associate- Labeling

Parexel
Parexel
4+ years
Not Disclosed
10 July 26, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Join Us at Parexel: Uniting for a Healthier World

At Parexel, we are driven by a shared mission to improve global health. Whether through clinical trials, regulatory consulting, or market access, our work is fueled by a deep conviction in our purpose. Every role at Parexel contributes to developing therapies that ultimately benefit patients. We approach our work with empathy and a personal commitment to making a difference.

Position: Regulatory Affairs Labeling

Qualifications and Experience:

  • Minimum of 4 years of experience in drug development, with a focus on labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.
  • Strong knowledge of key labeling regulations and guidance, with hands-on experience in label development (CCDS, USPI, packaging).
  • Proven ability to research and create comparator labeling documents.
  • Experience in preparing annual reports and collaborating with Technical Operations (Tech Ops) for artwork implementation.
  • Proficiency in Structured Product Labeling (SPL), including all aspects, types, and troubleshooting.
  • Skilled in managing the review and approval of labeling within a document management system.
  • Familiarity with electronic document management systems and experience in electronic submissions.
  • Expertise in Life Cycle Management, including post-approval labeling submissions and PSUR submissions.

At Parexel, our values align with our mission, driving us to achieve great things together. If you share our passion and commitment to making a difference in healthcare, we invite you to join our team.