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Regulatory Affairs Specialist Project Lead I

5-10 years
Not Disclosed
10 July 1, 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

Job Description: Global Regulatory Strategy Lead (Immunology)

Location: Fully Remote

Role Overview: The Global Regulatory Strategy Lead is accountable for the development and execution of innovative and value-added global regulatory strategies for immunology products in early development. This role includes formulating the Global Regulatory Project Strategy (GRPS) and leading the development of a global Health Authority (HA) interaction plan and strategy in collaboration with the Global Regulatory Team (GRT). The lead is responsible for communicating key outcomes to senior management.

Key Responsibilities:

  • Lead the development and execution of global regulatory strategies for immunology products in early development.
  • Formulate the Global Regulatory Project Strategy (GRPS).
  • Develop and manage a global Health Authority (HA) interaction plan and strategy in collaboration with the Global Regulatory Team (GRT).
  • Communicate key outcomes and strategies to senior management.

Education and Experience:

  • Required: BS/BA degree in a relevant scientific discipline.
  • Preferred: Advanced degree (PharmD, PhD, MD, DVM, or MSc in Biology, Life Science, or related field).
  • At least 8-10 years of relevant pharmaceutical/biotechnology experience in R&D.
  • At least 5 years of relevant Regulatory Affairs experience (regional and/or global) in early development.