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Regulatory Affairs Consultant

Parexel
Parexel
8+ years
Not Disclosed
10 Sept. 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, 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 Description:

We are looking for a highly experienced professional with 8+ years in lifecycle management of approved drug products, including tablets (oral solids), syrups (oral liquids), and parenterals (injectables) for the EU market.

Key Responsibilities:

  • Demonstrate a strong understanding of the regulatory framework and regional trends for various application types and procedures.
  • Lead or contribute to the planning, preparation (including authoring when relevant), and submission of regulatory maintenance documents, starting with simpler submissions and progressing to more complex ones from a global and/or regional perspective.
  • Possess working knowledge of EU/US regulatory procedures, including post-approval requirements. Familiarity with ROW market regulations is a plus.
  • Handle CMC-related health authority queries effectively.
  • Understand the regulatory landscape for small and large molecules across all regions, including knowledge of global pharmaceutical legislation and ICH guidance related to CMC.
  • Collaborate closely with cross-functional teams aligned with product responsibilities.
  • Develop, execute, and maintain submission delivery plans and content plans, providing proactive status updates to stakeholders.
  • Prepare, review, and submit safety variations to Health Authorities, along with managing post-approval CMC updates as needed.
  • Prior experience with Regulatory Information Management Systems, such as Veeva Vault, is desirable.
  • Exhibit strong communication skills and the ability to work independently.

If you are ready to contribute to our mission and drive regulatory excellence, we would love to hear from you!