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Regulatory Science Analyst

1+ years
Not Disclosed
10 Nov. 23, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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 Summary
Join Pfizer’s Regulatory team as a Regulatory Jr. Analyst, supporting product registrations and post-approval changes throughout the product lifecycle for the assigned portfolio. You’ll collaborate with local and regional teams, maintain compliance with regulatory standards, and stay informed on legislation and market requirements.

Key Responsibilities:

  • Gain a thorough understanding of local and Cluster market regulatory requirements and processes.
  • Collaborate with local Regulatory teams, Regional Hubs, and other stakeholders (e.g., PGS, Submission Management, GRO, GCMC) to execute regulatory strategies for submissions, line extensions, and post-approval changes.
  • Ensure internal systems and databases are consistently updated.
  • Evaluate data from Headquarters and other departments for technical report preparation, partnering with the Regional Hub and PGS.
  • Participate in preparing responses to Health Agency (HA) queries, working closely with local and regional stakeholders.
  • Monitor HA websites regularly for updates related to product registration and regulatory changes.
  • Stay current on local regulations, trends, and updates, and communicate them effectively to the team.
  • Maintain all Pfizer systems, share points, and spreadsheets associated with registration activities.
  • Complete corporate and regulatory training in a timely manner.
  • Contribute to local regulatory initiatives that align with Pfizer’s values, emphasizing compliance, innovation, and talent development.

Qualifications:

  • Experience: Minimum 1 year as a Regulatory Jr. Analyst in pharmaceuticals (for human use).
  • Education: Bachelor’s degree in Chemistry, Pharmacy, or a related life science field.
  • Skills:
    • Change agility and adaptability.
    • Knowledge of local regulatory requirements and Cluster market standards.
    • Strong technical and scientific understanding of pharmaceutical products.
    • Proficiency in English (preferred).
    • Team player with excellent collaboration skills.

Why Pfizer?
Pfizer is committed to promoting an inclusive workplace, offering equal opportunities to all employees and applicants regardless of race, gender, sexual orientation, disability, or other protected statuses.

EEO & Employment Eligibility:
Pfizer ensures equal employment opportunities and values diversity, innovation, and the development of its talent.

Apply today to join a world leader in pharmaceutical innovation and make an impact in the field of regulatory affairs!